A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
April 30, 2015
- CDC Sounds Alarm over Indiana HIV Outbreak
- CDC Researching Human Bird Flu Vaccine Just in Case
- Ebola Drug Cures Monkeys Infected with West African Virus Strain
- CAP and NSH Release New Guideline to Improve Patient Safety
- Inexpensive Assay Differentiates Two Diffuse Large B-Cell Lymphoma Subtypes
- Blood Test to Guide RA Tx Proves Cost Effective
- Mitochondria Editing Tried in Mice
- 2-Core Biopsy Could Replace 12-Core Biopsy for Prostate Cancer Detection: Study
- A Boost for Prenatal Cell Free DNA Testing
- MRSA Can Be Controlled with Strict IC Protocols Enforced over Time, Study Finds
- Study Rules out Link between Autism and MMR Vaccine Even in At-Risk Kids
- Child Malaria Vaccine: Final Trials Bring Hope
- Only One-Quarter of Federal Agency IT Officials Polled Say Their Network Data is Protected in Transit
- New AHRQ Study Examines Health IT Tool Intended to Improve Medication Monitoring
- 5 Ways Health IT Can Help Children in Poverty
View Previous Issues - Healthcare News Archive
CDC Sounds Alarm over Indiana HIV Outbreak
The Centers for Disease Control and Prevention (CDC) issued an urgent warning to health officials across the country about the HIV outbreak in a rural Indiana county, which has now infected 142 people. The CDC’s health alert advises health departments and healthcare providers on how to control HIV and hepatitis C outbreaks among injection drug users. Officials from the CDC and the Indiana Department of Health said they are increasingly alarmed by the outbreak of HIV and hepatitis C in Scott County, Ind., which they said is rare in the rural United States. “This is the first outbreak of its type that we have seen documented in recent years,” Dr. Jonathan Mermin, who leads the CDC’s HIV prevention center, told reporters. The vast majority of infected people are injection drug users, including those on methamphetamine and heroin, which Mermin said could be a harbinger of more outbreaks in similarly impoverished communities. “This outbreak that we’re seeing in Indiana is really a tip of an iceberg of a drug-abuse problem that we see in the United States,” he added. Nearly 9 in 10 people who tested positive for HIV have also been diagnosed with hepatitis C, according to a CDC report released Friday.
CDC Researching Human Bird Flu Vaccine Just in Case
While the risk to humans from the current avian flu crisis remains low, a senior Center for Disease Control official said that the agency is preparing for the possibility of infection in humans just in case. The agency is closely studying the virus and researching a potential vaccine, which could be used for humans if needed. Alicia Fry, a CDC medical official, described the steps as routine public health measures. She noted that thus far genetic analysis of the devastating virus -- the most significant avian flu crisis to hit the poultry industry in more than 30 years -- has not shown any of the markers that are known to be associated with causing increased severity of illness in people or the increased ability to spread to people. "While we are cautiously optimistic that there will not be human cases, we must be prepared for that possibility," Fry said.
Ebola Drug Cures Monkeys Infected with West African Virus Strain
An experimental drug has cured monkeys infected with the Ebola virus, US-based scientists have said. The treatment, known as TKM-Ebola-Guinea, targets the Makona strain of the virus, which caused the current deadly outbreak in West Africa. All three monkeys receiving the treatment were healthy when the trial ended after 28 days; three untreated monkeys died within nine days. Scientists cautioned that the drug's efficacy has not been proven in humans. At present, there are no treatments or vaccines for Ebola that have been proven to work in humans. University of Texas scientist Thomas Geisbert, who was the senior author of the study published in the journal Nature, said: "This is the first study to show post-exposure protection... against the new Makona outbreak strain of Ebola-Zaire virus." Results from human trials with the drug are expected in the second half of this year.
Revamped MEDTECH Act Looks to Exempt Low-Risk Software from FDA Guidance
Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo unveiled a revamped version of their Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act, which aims to exempt low-risk medical software and mobile apps from regulation by the U.S. Food and Drug Administration while clarifying which offerings fall under federal authority. The new bill updates proposed legislation initially introduced to the Senate last December and is more granular in distilling which software should not be regulated by the FDA. Software intended to support administrative and operational functions for healthcare facilities, for instance, is excluded from regulation, as are tools to monitor wellness "unrelated to the diagnosis, cure, mitigation, prevention or treatment" of a specific disease or disorder.
APHL Represented at CLIAC Meeting
On April 15 and 16, the Clinical Laboratory Improvement Advisory Committee met at CDC to discuss updates from CDC, CMS and FDA. The meeting was led by APHL member and chair, Dr. Burton Wilcke, University of Vermont Department of Medical Laboratory & Radiation Sciences, and public health laboratories were represented by Paula Vagnone, Minnesota Public Health Laboratory Division. Presentations were also given on laboratory information exchange in health IT and laboratory safety and quality. Dr. Michael Pentella, William A. Hinton State Laboratory, presented "Public Health Laboratory Perspective on Safety and Quality." For copies of the presentations, visit CLIAC's website. Detailed meeting minutes will be posted on the same site in 60–90 days.
CAP and NSH Release New Guideline to Improve Patient Safety
The College of American Pathologists (CAP) and the National Society for Histotechnology (NSH) have released the first evidence-based guideline to ensure patient safety through the uniform labeling of paraffin blocks and slides. The guideline, “Uniform Labeling of Blocks and Slides in Surgical Pathology,” is now available in the online edition of Archives of Pathology & Laboratory Medicine. The new guideline includes 12 statements to assist pathology laboratories in developing standardized block and slide labeling practices. Key points of the recommendations include:
- Laboratories should ensure that all blocks and slides are clearly labeled using two patient identifiers.
- Laboratories should ensure that the accession designation used on the surgical pathology report, and all blocks and slides from that accession, include the case type, year, and a unique accession number.
Inexpensive Assay Differentiates Two Diffuse Large B-Cell Lymphoma Subtypes
Although it has been known for over a decade that two subtypes of diffuse large B-cell lymphoma (DLBCL), a form of non-Hodgkin lymphoma, have different prognoses and may respond differently to targeted treatment, routinely distinguishing between them has proved challenging. Now, a team of researchers in France has developed an inexpensive classification method using a panel of 14 gene signatures and garden-variety lab equipment that may provide competition for commercial products being developed as companion diagnostics. The method, published online in the Journal of Molecular Diagnostics, is based on assessment of publically available Affymetrix RNA data on the two DLCBL subtypes — germinal center B-cell-like (GBC) and activated B-cell-like (ABC).
Blood Test to Guide RA Tx Proves Cost Effective
Using the results from a multibiomarker disease activity (MBDA) blood test to guide treatment decisions in rheumatoid arthritis (RA) can improve functional status and cost efficiency. Using a decision analysis, researchers led by Kaleb Michaud, PhD, at the University of Nebraska Medical Center, Omaha, determined that enhanced control of disease activity from treatment refinements based on results from the MBDA test resulted in an improvement in Health Assessment Questionnaire (HAQ) scores and cost savings over 10 years. The test was also projected to increase quality-adjusted life years (QALYs) by about 1 month over this time horizon.
Mitochondria Editing Tried in Mice
Researchers have developed a technique to edit out bits of mitochondrial DNA that could otherwise pass on incurable diseases, a study in mice shows. Salk Institute scientists used specifically engineered molecular scissors to snip out mutations in embryos, leaving healthy DNA intact. They hope it could one day be used to prevent human mitochondrial diseases. But experts say though it is a "technical masterpiece", it raises ethical and scientific challenges. Mitochondria are tiny powerhouses found inside nearly every cell in the body, generating energy necessary for essential functions. They carry their own DNA - which is passed on from mothers to their children. Unlike DNA found in the nuclei of cells, this does not affect characteristics such as appearance. But if inherited mitochondrial DNA is defective, children can have life-limiting conditions involving muscles weakness and blindness. Reporting in the journal Cell, scientists tested molecular scissors on mice with two different types of mitochondrial DNA (mtDNA).
David King, of the group, Human Genetics Alert, had his own warning. "This research is unethical. It threatens to usher in the future of genetically modified designer babies. "We must extend the ban on human genetic engineering to create a global treaty." Meanwhile, other research from China involving separate technology on the more abundant DNA found in the nuclei of human cells, has led scientists to question how far such technology should ethically go.
2-Core Biopsy Could Replace 12-Core Biopsy for Prostate Cancer Detection: Study
An imaging-guided two-core biopsy to detect prostate cancer yields comparable results to the traditional 12-core random biopsy, a new randomized trial suggests. "In patients with intermediate and high suspicion of prostate cancer on MRI, Prostate Imaging Reporting and Data System (PIRADS) grade 4 or 5, only 2 MRI/TRUS (transrectal ultrasound) targeted cores are necessary to confirm the diagnosis of clinically significant prostate cancer," said lead author Dr. Eduard Baco of the University of Oslo in Norway. "Our research team was surprised by the fact that traditional random systematic biopsy found comparable number of cancers (detection rate of all and clinically significant cancers) with the MRI/TRUS fusion biopsy technique," he told Reuters Health by email. "However, it is important to mention that the traditional random biopsies were performed by two senior urologists with more than 20 years' experience in the traditional prostate biopsy technique." The study was published online April 7 in European Urology.
A new study found that a cell-free DNA (cfDNA) blood test—used for diagnosing Down syndrome and two less common chromosomal abnormalities and done between 10 and 14 weeks of pregnancy—may be more effective than standard non-invasive tests. The study supports utility of the test in broader populations than have been considered in the past. Prior studies of cfDNA have been in women who already were at risk and who were tested just before they had an invasive test. The new findings are from a blinded, prospective study in an unselected population of women presenting for aneuploidy screening. cfDNA tests look at a small percentage of fetal DNA that exists in a pregnant woman’s blood. The DNA is then amplified using polymerase chain reaction and sequenced to allow for comparisons between relative amounts of each chromosome’s DNA. When a greater amount of DNA is found, it suggests the existence of some chromosomal conditions, such as Down syndrome. The study, which was published in the New England Journal of Medicine, followed the pregnancy outcomes of 16,000 women with an average age of 30.
Breath Test for Malaria Is in the Air
At present, diagnosing malaria can be a difficult process involving powerful microscopes and careful scanning of blood samples for tiny parasites in a technique discovered in 1880. But a more accessible method may be in the works. A team of Australian scientists has discovered that certain chemicals are present and can be detected in the breath of sufferers, raising the possibility of a cheap breath test to diagnose the deadly disease. Researchers at the Commonwealth Scientific and Industrial Research Organisation (CSIRO) were working with a group of subjects given controlled malaria infections who had volunteered to be part of studies to develop new treatments. When examining the breath of these infected volunteers, the scientists observed heightened levels of a number of chemicals that are normally almost undetectable. More specifically, these chemicals were four sulphur-containing compounds that had not been associated with any disease in the past. The team found that the levels of these compounds fluctuated over time in a way that correlated with the severity of the malaria infection, before effectively disappearing once they were cured. The fact that the compounds were detected at the very beginning of the infection has the researchers, hopeful the technique could result in quicker diagnoses.
Blood Test Can Help Avoid Unnecessary Drug Side Effects for Some Patients with Colorectal Cancer
Researchers have provided early evidence to suggest that a blood test could be used to identify patients with colorectal cancer who may benefit from more intensive chemotherapy. Their study was published in Clinical Colorectal Cancer (2015; doi:10.1016/j.clcc.2014.12.006). Colorectal, or bowel, cancer is the third biggest cancer killer in the United States. It is most commonly treated with a combination of chemotherapy agents, and outcomes can be improved by using additional drugs. However, this multidrug approach can increase side effects such as hair loss, low white blood cell count, diarrhea, and damage to the peripheral nervous system. The research team counted tumor cells in a patient's blood sample as a way of predicting who might benefit most. “We are interested in detecting cancer cells that have been shed from a patient's tumor and are circulating in their blood. In this study we wanted to see if the number of tumor cells in a blood sample could be linked to how well patients respond to intensive chemotherapy," said study co-leader Professor Caroline Dive, PhD, from the Cancer Research UK Manchester Institute at The University of Manchester, which is part of the Manchester Cancer Research Centre in the United Kingdom.
HCV Linked to Higher Cancer Risk
People with hepatitis C (HCV) appear to be more prone to cancer -- not just liver tumors -- than those without the infection, a researcher said here. In a retrospective analysis of medical records, those with HCV were more than twice as likely to have any of a range of common cancers, according to Anders Nyberg, MD, of Kaiser Permanente Southern California in San Diego.
MRSA Can Be Controlled with Strict IC Protocols Enforced over Time, Study Finds
Methicillin-resistantStaphylococcus aureus control in the long term is feasible when a bundle of infection control precautions are strictly enforced over time, according to a study in Infection Control & Hospital Epidemiology.
Researchers examined the infection control program at the University Hospital Basel in Switzerland. The program was established in 1993 and it has included:
• Strict contact precautions with single rooms for MRSA-colonized/infected patients
• Targeted admission screening of high-risk patients and healthcare workers at risk for carriage
• Molecular typing of all MRSA strains
• Routine decolonization of MRSA carriers
• Targeted admission screening of high-risk patients and healthcare workers at risk for carriage
• Molecular typing of all MRSA strains
• Routine decolonization of MRSA carriers
Study Rules Out Link between Autism and MMR Vaccine Even in At-Risk Kids
At least a dozen major studies have found that early childhood vaccines do not cause autism. But one possibility remained: that, immunizations could cause autism in a small group of children who were already primed to develop the disorder. Now, new research has ruled out that possibility too. A study of nearly 100,000 children found that toddlers known to have an elevated risk of autism were no more likely to be diagnosed with the disorder if they were vaccinated against measles, mumps and rubella than if they weren’t. What’s more, the diagnosis rate for high-risk children who were vaccinated was the same as for immunized children with no family history of the disorder, according to the report published in the Journal of the American Medical Assn.
Child Malaria Vaccine: Final Trials Bring Hope
Final clinical trials of a malaria vaccine - the first to reach this stage - suggest it could help protect millions of children against malaria. But tests on 16,000 children from seven African countries found that booster doses were of limited use and vaccines in young babies were not effective. After children aged 5-17 months were given three doses of the vaccine, the immunisation was only 46% effective. But experts say getting the vaccine this far is a scientific milestone. Data from the trial published in The Lancet showed that the success rate fell to even lower levels in younger infants. Scientists have been working on the vaccine for more than 20 years, but observers believe there is still a long way to go. RTS,S/AS01 is the first malaria vaccine to reach advanced trials and show any sign of working in young children.
Benefits of HPV Vaccine Can Be Seen in High School Girls, Study Says
Years before the HPV vaccine prevents women from getting cervical cancer, it protects them against genital warts and cervical dysplasia, new research suggests. A study of more than 26,000 teen girls in Ontario, Canada, finds that those who received all three doses of Gardasil were 44% less likely than their unvaccinated peers to be diagnosed with cervical dysplasia during their high school years. It also appears that the vaccine reduced the risk of genital warts by 43%, researchers reported in the journal Pediatrics.
Scientists Use Innovative Methods, New Technology to Increase HPV Vaccinations in Florida
Even though a safe HPV vaccine is available that can prevent several types of cancer, less than half of American teens youth in the U.S. receive the vaccine. Now a team of researchers, including four from the University of Florida Institute for Child Health Policy, has increased the odds of adolescents starting the vaccine series by 140 percent among girls and 60 percent among boys. The researchers not only identified key factors that influence how likely parents are to start the vaccination series, they also implemented an innovative multipronged approach that included mailings and using new technology in primary care clinics. The findings, published this month in the Journal of Adolescent Health, could shape how providers approach HPV vaccination in their clinics and help prevent up to 17,500 new cancer cases per year.
Vaccine Spurs Immune Response to Fight Aggressive Cancers in Mice
In a step toward personalized vaccines against cancer, scientists report they have developed an immune-system therapy that knocks out several types of aggressive tumors in mice. German researchers said the findings, reported April 22 in the journal Nature, could lead to a "blueprint" for developing tailored vaccines for a range of cancers. Such vaccines would be designed for individual patients, based on the specific genetic mutations in their tumors.
Smog May Be Harming Your Brain
Long-term exposure to tiny particles of air pollution may be linked to subtle changes in the brain that could lead to thinking and memory problems, a new study suggests. These fine particles, smaller than 2.5 micrometers in diameter (much smaller than a pinhead), are released by burning wood or coal, car exhaust and other sources. Long-term exposure may shrink the brain and increase the risk of silent strokes, the researchers suggested. With a silent stroke, a people might not even be aware they have experienced one. "Our findings suggest that air pollution is associated with insidious effects on brain aging, even in relatively healthy older people," said lead researcher Elissa Wilker, an instructor in medicine at Harvard Medical School in Boston.
CDC Using New Technology to Track Listeria Illnesses
The government is relying on some new technology — as well as a bit of luck — to track an outbreak of life-threatening listeria linked to Blue Bell ice cream products. Texas-based Blue Bell Creameries recalled all its products as listeria was found in a variety of the company's frozen treats. The investigation has been helped by technology called whole genome sequencing that maps all an organism's DNA. While the sequencing has been a staple of medical research, it has only recently been used regularly to track listeria outbreaks.
Only One-Quarter of Federal Agency IT Officials Polled Say Their Network Data Is Protected in Transit
About 26 percent of federal agency IT decision makers polled believe the data transmitted across their networks are fully protected, according to one major finding in a new industry-sponsored survey released last week. And the top challenges in protecting such data are budget constraints, limited resources and the complexity and impact on network performance, the survey [ pdf] added. The online survey was conducted by research firm Market Connections, which polled 200 federal IT officials representing 60 agencies. The survey, which was conducted with technology company Brocade.
New AHRQ Study Examines Health IT Tool Intended to Improve Medication Monitoring
An electronic tool to support laboratory monitoring between primary care office visits improved low-density lipoprotein (LDL) testing intervals for patients, but didn’t improve hemoglobin A1c or LDL control, according to an Agency for Healthcare Research and Quality (AHRQ)-funded study. AHRQ is an agency within the U.S. Department of Health and Human Services. In a randomized controlled trial, researchers examined the clinical impact of a health information technology (IT) tool designed to improve between-visit ordering and tracking of laboratory testing for more than 3,500 primary care patients who were prescribed oral medications for hyperlipidemia, diabetes, and/or hypertension over a 12-month period. The study “Randomized Trial of a Health IT Tool to Support Between-Visit Based Laboratory Monitoring for Chronic Disease Medication Prescriptions,” appeared online January 6i n the Journal of General Internal Medicine.
5 Ways Health IT Can Help Children in Poverty
In a new white paper by the Samsung Innovation Center at Children's Health Fund, researchers examine how technology could help improve the health of children in poverty across the country. The white paper expands upon the ways technology can be used to drive major change for those in need, and it puts forth five recommendations:
- New technologies must be designed for or adapted to the needs of children.
- The federal Centers for Medicare and Medicaid Services should create a special fund to incentivize the development of technologies to improve accessibility and quality of healthcare for medically underserved children.
- Training curricula for health sciences students and providers should include education regarding the effective use of technology in improving healthcare.
- Efforts should be made to ensure that families fully understand how new technologies can improve the quality and availability of health information relevant to their children.
- Innovative ways to make healthcare more accessible and efficient, especially for underserved children, must be financially supported.
Scientists to Share Real-Time Genetic Data on Deadly MERS, Ebola
Genetic sequence data on two of the deadliest yet most poorly understood viruses are to be made available to researchers worldwide in real time as scientists seek to speed up understanding of Ebola and MERS infections. The project, led by British scientists with West African and Saudi Arabian collaboration, hopes to encourage laboratories around the world to use the live data -- updated as new cases emerge -- to find new ways to diagnose and treat the killer diseases, and ideally, ultimately, prevent them.
The Next Step in Health IT? Virtual Doctors’ Visits
Amid congressional discussion about making electronic health records widespread, senators have turned their attention to laws governing virtual medical care, often called telehealth. During a recent hearing, Sen. Brian Schatz, D-Hawaii, noted that telehealth services, which could include using wireless medical devices to monitor patients while they're at home, are not always reimbursable under Medicare. For instance, he said, some reimbursements are available for patients in rural settings, but not urban ones. During the hearing, Jonathan Linkous, chief executive of the American Telemedicine Association, noted that the lack of broadband connectivity was a barrier to widespread telehealth delivery. And while the Federal Communications Commission has focused on bringing broadband to citizens' homes, "we do need to start looking at this issue as 'broadband to the person'" instead of tying connectivity to physical locations, Linkous added.
NIH to Spend $20B on Health IT
The National Institutes of Health's Information Technology Acquisition and Assessment Center is awarding $20 billion in IT work. The money will be disbursed among 65 companies across the country. NIH announced the government-wide acquistion contract, which it refers to as GWAC, April 17. "Our vision was to create a strong suite of contracts which meet the IT needs of not only NIH but the entire federal landscape," Diane J. Frasier, director of the office of Acquisition and Logistics Management and head of the contracting activity at NIH, said in a statement.
ONC's Karen DeSalvo Outlines 3 Steps to Interoperability
National Coordinator for Health IT Karen DeSalvo continues to tout "the bright future" of health IT, outlining in a post at Health Affairs what needs to be done to get to full interoperability. Her steps to getting to interoperability include:
- Standardizing application programming interfaces and implementation standards.
- Creating clarity around the environment of trust. "What are the shared expectations and actions around data security and privacy?" she asks.
- Prociding incentives for interoperability and the appropriate uses of electronic health information.
Experts Underline the Need for Strong Laboratory System
Experts have underlined the need for developing a strong laboratory system which is crucial to supporting prevention and treatment of infectious diseases at a seminar on 'advancing quality and outcomes in laboratory medicine' in Pune (India). Organised by Becton, Dickinson (BD) and company, a global medical technology firm, the seminar saw participation from city's pathology experts, lab managers in large number. Ana Stankovic, of BD Diagnostics elaborated on the importance of preanalytical processes.
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