A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
August 06, 2015
- Hospitals Must Work Together to Prevent Superbug Spread, CDC Says
- Experimental Ebola Vaccine Tested in Guinea Shows Promise, Report Says
- CDC Head Says Sierra Leone in Strong Place to Deal with Ebola as Concerns Grow with New Cases
- At AACC, Clinical Labs Air Concerns Regarding FDA's Draft LDT Guidance
- Curbing Inappropriate Lab Tests
- New Enterovirus-D68 Assay Allows for Rapid Testing
- Scientists Have Identified Five Types of Prostate Cancer, Each With a Distinct Genetic Signature
- High-Grade Prostate Cancer Linked to Low Testosterone
- Blood Test Predicts Prognosis for Traumatic Brain Injuries
- Physicians Blamed for Low HPV Vaccination Rates
- CDC Funding Helps States Address Infectious Disease Threats
- CDC: 53 Million Adults in the U.S. Live with a Disability
- The Health IT Safety Center Roadmap: What’s Next?
- Senators Push Bill to Authorize EINSTEIN 3A, Shore Up 'Insufficient Cybersecurity Practices' Governmentwide
- Feds Months Away from Broader Cybersecurity 'Sprint' Strategy following OPM Breaches
View Previous Issues - Healthcare News Archive
Hospitals Must Work Together to Prevent Superbug Spread, CDC Says
Superbugs – germs that have evolved to become resistant to antibiotics and other medical treatments – are on the loose, infecting more than 2 million people in the U.S. every year and killing at least 23,000. But a new analysis from the U.S. Centers for Disease Control and Prevention suggests that coordinated efforts to combat antibiotic-resistant infections could reduce the number of infections in healthcare facilities by more than half a million over the course of five years. "If you’re a hospital doing a great job but the hospital down the street isn’t, your patients are at risk," said CDC director Dr. Tom Frieden, during a phone call with reporters Tuesday afternoon. "Facilities that go it alone can’t protect their own patients." The CDC'S new analysis, a mathematical simulation, was released Tuesday as a CDC Vital Signs report and in the agency's Morbidity and Mortality Weekly Report. Researchers looked at four types of healthcare-associated infections: CRE, multidrug-resistant Pseudomonas aeruginosa, invasive methicillin-resistant Staphylococcus aureus (MRSA), and C. difficile.
Experimental Ebola Vaccine Tested in Guinea Shows Promise, Report Says
An experimental Ebola vaccine being tested in the West African nation of Guinea during the continuing outbreak of the viral disease has shown promising initial results, according to a report on the clinical trial that was published Friday. The report, in the British medical journal The Lancet, which analyzed 7,651 individuals, more than 3,500 of whom were vaccinated, indicated that the vaccine “might be highly efficacious and safe in preventing Ebola virus disease.” The results are “very encouraging,” said Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, who was not involved in the trial, which he called a “very difficult study under very difficult circumstances.” He added that the study’s unorthodox design “makes it difficult to get the precise information you need,” but that, “even in the absence of that, the results are impressive.”
CDC Head Says Sierra Leone in Strong Place to Deal with Ebola as Concerns Grow with New Cases
Sierra Leone is in a stronger place than it was six months ago to fight Ebola, but the new challenge is to get to zero cases, the director of the U.S. Centers for Disease Control and Prevention said during a visit, as new cases emerged in the city and in an area that had not seen the deadly virus for months. Two new cases of Ebola surfaced in Sierra Leone's Northern Tonkolili District after a man died last week. The district had not had a single case of Ebola in five months. The victim contracted the disease in the capital, traveled to his home village, and was treated for a fever at the local hospital but authorities didn't call the Ebola emergency number. He didn't have a burial that followed special procedures required for Ebola victims. Dr. Thomas Frieden, CDC director, said it was important that the case was identified and not missed, and he was impressed with the speed of the response. "The challenge now is to get to zero cases and that is not going to be easy," he said. "Authorities must not let down their guard. The country should keep its guard up."
Oxytocin Receptor May Influence Postpartum Depression, Be Potential Biomarker
Women with a history of depression prior to their pregnancy face an increased chance of developing postpartum depression (PPD) — as much as 41 percent, according to the American Psychological Association. An estimated nine to 16 percent of women without a history of mental illness will also experience PPD. Is there any way of knowing which of these women will be affected? A new study published in Frontiers in Genetics may have found a potential biomarker for the condition. The biomarker stems from the oxytocin receptor gene (OXTR). Oxytocin, also (and more commonly) known as the love hormone, plays a role in everything from a healthy birth to mood and emotional regulation. Previous studies have already associated low levels of oxytocin with PPD. In this particular study, researchers hypothesized that “individual epigenetic variability at OXTR may impact the development of PPD and that such variability may be central to predicting risk.”
FedEx no Longer to Transport Bioterror Germs in Wake of Anthrax Lab Mishaps
Shipping giant FedEx no longer is willing to transport packages containing research specimens of potential bioterror pathogens in the wake of high-profile safety mistakes by an Army lab that unknowingly shipped live anthrax for years, according to a letter the company sent to federal regulators and obtained by USA TODAY. FedEx’s refusal to transport these kinds of specimens is drawing concern among officials at major laboratories, who say it was the primary way they sent and received critical samples used to diagnose diseases and for the development of vaccines, treatments, tests and detection equipment. Neither UPS nor the U.S. Postal Service will transport the specimens. “It potentially is a devastating blow,” said James Le Duc, director of the Galveston National Laboratory in Texas, a major high-containment research facility that has two to three shipments a month. Le Duc said much of infectious-disease research involves pathogens found in the wild in other parts of the world, which requires the shipment of specimens.
“Everybody is kind of dumbfounded that this has happened,” Le Duc said Wednesday. If there were an outbreak of disease caused by a potential bioterror pathogen, fast shipments would be critical. “If that were to happen now, most public health labs could not ship specimens overnight to CDC, and the national public health response would be disrupted and delayed,” said Eric Blank, a senior director at the Association of Public Health Laboratories, whose members include state health department labs.
Drones Might Fly Blood Samples to Clinics, Study Finds
Drones can be used to transport blood samples short distances, a new study finds. Johns Hopkins University researchers found that common and routine blood tests were not affected when blood samples spent up to 40 minutes traveling on hobby-sized drones. The study was published July 29 in the journal PLoS One. The findings from test flights in the United States are promising news for patients in areas with poor road networks. Drones could give isolated medical clinics quick access to lab tests required to diagnose and treat health problems, the researchers said.
Laboratory Testing / Diagnostics
At AACC, Clinical Labs Air Concerns Regarding FDA's Draft LDT Guidance
Clinical laboratory managers aired their concerns during the American Association for Clinical Chemistry meeting regarding the draft guidance issued last fall by the US Food and Drug Administration on how it plans to regulate lab-developed tests. They are particularly worried about how to define what is and what is not a lab-developed test as well as the time and expense of taking an LDT through the FDA clearance or approval process, and how such regulations may affect patient care. In addition, they are concerned about how any overlap between FDA and Centers for Medicare and Medicaid Services regulations would be handled. "We have to applaud the FDA for seeking to improve the quality of lab testing and ensuring tests meet clinical expectations," said James Nichols, the associate medical director of clinical operations at Vanderbilt School of Medicine, before then going on to list a dozen concerns he has with the draft LDT guidance and its possible implementation. LDTs are currently regulated by CMS under the Clinical Laboratory Improvement Amendments, which regulates laboratory testing in the U.S. This, though, has led to two paths through which a test gets to market: commercially developed tests that go through FDA and LDTs that go through CLIA. "It's created an uneven playing field," said Alberto Gutierrez, the director of FDA's Office of In Vitro Diagnostics and Radiological Health, at AACC.
Curbing Inappropriate Lab Tests
A computerized alert system shows promise in tamping down on unnecessary laboratory tests and saving money in the process, a new study indicates. “Appropriateness of laboratory test requests is a key driver for optimal use of laboratory resources and for improving patient's outcome,” according to an article on the study’s results, published in Clinical Biochemistry. Yet, evidence is mounting that too many inappropriate lab tests are being requested and that the incidence is high—ranging anywhere from 23% to 67%. Inappropriate tests can have a number of clinical and other consequences, the article stated. Approaches to curbing this behavior, such as placing limits on the number of tests doctors can request or including test fees in computerized order entries, haven’t been consistently successful. Researchers decided to study the use of a computerized alert system that incorporated preset criteria for the “appropriateness” of 15 tests, and used pop-up alerts to signal when a violation of these criteria took place. The alert appeared in the order entry screen, explaining why the requested test violated a rule of appropriateness and was deemed as inappropriate. Doctors could decide whether to accept the alert’s suggestion. Researchers tested the effectiveness of this system in two clinical wards of the University Hospital of Parma, Italy, for 6 months. Overall, 22%, or 765 of 3,539 test requests, triggered the pop-up alert, resulting in the annulment of 591 tests. This represented 77% of the tests that received alerts and 17% of the tests requested. Over the 6-month period, researchers noticed a decline in the number of test requests that violated appropriateness criteria. They estimated that the hospital accrued nearly 13% in total financial savings from the annulled or withdrawn tests, during the 6-month study period.
New Enterovirus-D68 Assay Allows for Rapid Testing
A new assay is able to identify outbreaks of the human enterovirus (EV) D68. The EV-D68-specific reverse transcriptase polymerase chain reaction (RT-PCR) assay represents an improvement over the assay currently available from the Centers for Disease Control and Prevention (CDC), the authors say. The D68 subtype of enterovirus has been a recent focus of public health officials because it causes unusually severe respiratory illness in children. Todd N. Wylie and colleagues from the Washington University School of Medicine in St. Louis, Missouri, published the description of their real-time RT-PCR assay in the August issue of the Journal of Clinical Microbiology. To create the assay, the authors sequenced the genome of EV-D68 that circulated in St. Louis in 2014 and compared that with previously sequenced isolates. Using that method, they identified DNA sequences that are common to the D68 subtype, but not to other enteroviruses.
ACMG Adds Overused Genetic Tests to the Choosing Wisely Campaign
The American College of Medical Genetics and Genomics (ACMG) has released a list of five commonly misordered genetic tests that patients and providers should discuss prior to ordering. The evidence-based recommendations are part of Choosing Wisely, a national, multidisciplinary campaign that encourages physicians to avoiding wasteful or unnecessary medical tests, treatments and procedures. They say the current list of five items was selected as they were the most likely to improve quality and reduce costs related to genetic testing. The specific recommendations are:
- Do not order a duplicate genetic test for an inherited condition unless there is uncertainty about the validity of the existing test result.
- Do not order APOE genetic testing as a predictive test for Alzheimer disease.
- Do not order MTHFR genetic testing for assessing the risk of hereditary thrombophilia.
- Do not order HFE genetic testing for a patient without iron overload or a family history of HFE-associated hereditary hemochromatosis.
- Do not order exome or genome sequencing before obtaining informed consent that includes the possibility of secondary findings.
Some Results Don’t Bear Repeating
Critical values represent values that require immediate notification and clinical intervention to avoid or attenuate patient morbidity and mortality. Yet for decades, this communication has been delayed while the critical result is repeated. The practice of repeating all critical laboratory values before result notification to the responsible caregivers is long-standing and widespread. In the United States, a study of 340 hematology laboratories found that small hospitals repeated 83% of critical results and independent laboratories repeated 100% of critical results. This practice, however, can waste resources and delay treatment, observes hematology and pathology specialist Sharon Geaghan, MD. Geaghan addresses this issue in the JulyCLN Patient Safety Focus.
Paths to Validating Next-Gen Sequencing Assays
Because the Food and Drug Administration classifies most sequencers as research instruments, the majority of clinical NGS tests require full validation, not just verification. When validating a test, laboratories must compare a number of parameters, including accuracy, trueness, precision, reproducibility, and robustness, according to the CAP’s recommended principles and practices for validating clinical molecular pathology tests (Jennings L, et al. Arch Pathol Lab Med. 2009; 133:743–755).
- One approach to validating the accuracy of an NGS test is to compare test results with those of another clinical laboratory performing the same test and whose results are presumed to represent the gold standard.
- A second approach to validating the accuracy of an NGS test is to compare NGS results with the results obtained from a gold standard method. While Sanger sequencing once was considered the gold standard, Dr. Deignan noted there are cases where a Sanger test is negative while clinical exome sequencing is positive for a particular variant.
- A third approach to validating the accuracy of a next-gen test is to compare the NGS results with the results from well-characterized reference material.
A new consortium called Genome in a Bottle is developing the technical infrastructure, including reference standards, methods, and data, to enable translation of whole human genome sequencing to clinical practices. The National Institute of Standards and Technology, in April, made available for purchase its first reference material—8398, human DNA for whole-genome variant assessment. Additional reference materials for sequencing are under development.
2-Pound DNA Reader Could Help Fight Ebola, TB, HIV
California-based Cepheid recently unveiled a battery-powered, 2-pound, DNA-reading diagnostic device that can fit in a backpack. At just 2.2 pounds, a compact, battery-powered, DNA-reading medical device will soon be aiding the fight against Ebola, TB, HIV, and other infectious diseases in emerging countries, possibly by the first half of next year. Device-maker Cepheid ( CPHD -0.57%), of Sunnyvale, Calif., unveiled the machine, dubbed the Omni, at an analysts’ event in Atlanta on Monday night. It stands 9 inches high, 4.2 inches wide, and 3 inches deep, and could easily fit in a backpack.
FDA Grants OraSure Key Status for Rapid Ebola Test
The Food and Drug Administration has awarded OraSure Technologies' rapid Ebola test special status, allowing the company to market the test for use in areas where the virus is still circulating while it works toward final approval. The agency has granted emergency use authorization to nine other Ebola tests, but OraSure's is the first that does not require refrigeration at temperatures of up to 104 degrees — an important attribute for tracking a disease that spreads in the developing world. In its authorization, the agency notes that the test has only been approved for use on people demonstrating symptoms of Ebola in areas where the disease is present and a rapid test is more appropriate than a traditional nucleic acid-based test, which is more accurate, but can take longer to produce a result. It is not authorized for use in contact-tracing or airport screening.
Case Closed—Diagnosing on Mobile Devices Requires FDA Class II Clearance
This past February, the United States Food and Drug Administration (FDA) released updated guidance on mobile medical applications for the first time since 2013. This new guidance offers insight into the agency's plans for regulating the rapidly growing number of applications that turn smartphones and tablets into healthcare devices. While the agency is taking a hands-off approach to consumer-focused applications, such as those that track fitness levels or weight, it will continue to closely review and regulate software that transforms mobile technology into devices for diagnosis and treatment. From the FDA's standpoint, for example, mobile image-viewing software transforms a smartphone or tablet into a Picture Archiving and Communications Systems (PACS).
Research and Development
Scientists Have Identified Five Types of Prostate Cancer, Each with a Distinct Genetic Signature
Scientists have identified five types of prostate cancer, each with a distinct genetic signature. And by comparing 250 samples removed in surgery with the patients' subsequent progress, they have identified some types that are more likely to recur. Until now, there has been no reliable way to know which patients have the more aggressive cancers requiring the most urgent and intensive therapy. But much larger trials are still needed to be certain of these early results. Prof Malcolm Mason, of Cancer Research UK, which conducted the research with Addenbrooke's Hospital, Cambridge, said some of the types were like a pussycat – growing slowly and causing few problems, while others were like a tiger – growing and spreading aggressively. And researcher Dr Alastair Lamb said it could be possible to combine this genetic information with existing tests to identify patients most at risk.
High-Grade Prostate Cancer Linked to Low Testosterone
Low testosterone levels predict an increased likelihood of high-grade prostate cancer (PCa) being found as a result of a prostate biopsy, new findings suggest. In multivariable analysis, compared with a normal testosterone level, a low testosterone level was not significantly associated with a PCa diagnosis overall, but it was associated with a significant 2.1 times increased risk of high-grade PCa, the investigators reported online ahead of print inBJU International.
Blood Test Predicts Prognosis for Traumatic Brain Injuries
A new blood test could help emergency room doctors quickly diagnose traumatic brain injury and determine its severity. The findings, published July 10 in the Journal of Neurotrauma, could help identify patients who might benefit from extra therapy or experimental treatments. Until now, most physicians have relied on CT scans and patients' symptoms to determine whether to send them home and have them resume their usual activities or take extra precautions. However, CT scans can only detect bleeding in the brain, not damage to brain cells, which can happen without bleeding. Levels of one protein, called brain-derived neurotrophic factor (BDNF), taken within 24 hours of someone's head injury, could predict the severity of a TBI and how a patient would fare, they found. While healthy people averaged 60 nanograms per milliliter of BDNF in their bloodstreams, patients with brain injuries had less than one-third of that amount, averaging less than 20 nanograms per milliliter, and those with the most severe TBIs had even lower levels, around 4 nanograms per milliliter. Moreover, patients with high levels of BDNF had mostly recovered from their injuries six months later. But in patients with the lowest levels of BDNF, symptoms still lingered at follow-up. The results suggest that a test for BDNF levels, administered in the emergency room, could help stratify patients.
Pancreatic Cancer Urine Test Hope
A simple urine test that could detect pancreatic cancer much earlier than at present has been developed by scientists. They found a protein "signature" only present in people with the disease. Pancreatic cancer is often very advanced by the time it is diagnosed - and only 3% of patients are alive five years after diagnosis. Out of 1,500 proteins found in the urine samples, three - LYVE1, REG1A and TFF1 - were seen to be at much higher levels in the pancreatic cancer patients, providing a "protein signature" that could identify the most common form of the disease. The signature was found to be 90% accurate. Patients with chronic pancreatitis were found to have lower levels of the same three proteins.
Scientists Suggest New Way to Predict Lung Cancer Risk
Scientists may someday predict lung cancer risk by examining the telomeres that protect your DNA. People with long telomeres are at increased risk for lung cancer but not other types of cancer, the researchers found. Telomeres are protective caps of DNA that prevent damage to the ends of chromosomes. Telomere length naturally shortens with cell division. "Our work provides compelling evidence of a relationship between long telomeres and increased risk for lung adenocarcinoma," said lead author Brandon Pierce, an assistant professor of public health sciences at the University of Chicago. "The prevailing hypothesis has been that short telomeres are bad for health, but it appears that this does not necessarily translate to some types of cancer," he added. The study was published July 29 in the journal Human Molecular Genetics.
Public Health and Patient Safety
Physicians Blamed for Low HPV Vaccination Rates
Physicians must take responsibility for improving the rate of human papillomavirus (HPV) vaccinations among teenagers, according to Anne Schuchat, MD, assistant surgeon general and director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention. Overall, US teenagers had more vaccinations in 2014 than in previous years, including against HPV, said Dr Schuchat, when discussing the results of a new survey in a press conference held July 30. But most parts of the country are still lagging, primarily because physicians are not doing enough, she said. "We think the principle road block is providers not recommending the vaccine," she said. Researchers from the Centers for Disease Control and Prevention published the findings from a survey of 20,827 teenagers in the July 31 issue of the Morbidity and Mortality Weekly Report.
CDC Funding Helps States Address Infectious Disease Threats
The Centers for Disease Control and Prevention (CDC) announced awards of nearly $110 million to help states and communities strengthen their capacity to track and respond to infectious diseases. The awards represent an increase of about $13 million over fiscal year 2014 funding, with increases going to vaccine-preventable-disease surveillance, foodborne-disease prevention and advanced molecular detection, among other projects.
The funding is allocated through the Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement (ELC), with a goal of helping states fight infectious disease outbreaks more quickly and develop better interventions to protect the public’s health. Of the nearly $110 million, $51 million is provided through the Affordable Care Act’s Prevention and Public Health Fund. That funding will support:
- Infectious disease surveillance and outbreak response
- Public health laboratories
- Health information systems
- Efforts to combat zoonotic, vector-borne and foodborne diseases; vaccine-preventable infections; influenza; and healthcare-associated infections.
CDC: 53 Million Adults in the U.S. Live with a Disability
In the United States, one out of every five adults has a disability, according to a new study published by the Centers for Disease Control and Prevention. The most common functional disability type was a mobility limitation – defined as serious difficulty walking or climbing stairs – reported by one in eight adults, followed by disability in thinking and/or memory, independent living, vision, and self-care. The researchers found that the highest percentages of people with disabilities are generally in Southern states, for example Alabama (31.5 percent), Mississippi (31.4 percent), and Tennessee (31.4 percent). The report did not determine why differences occur by state; however, states in the South tend to have some of the higher rates of chronic diseases, such as heart disease and diabetes, which may also be associated with disability. “We are all at risk of having a disability at some point in our lifetime,” said CDC Director Tom Frieden, M.D., M.P.H. “Health professionals and health care systems need to meet the needs of this growing population.”
GlaxoSmithKline Sees Staged Roll-Out of Malaria Vaccine
The world's first malaria vaccine, which won a green light from European drugs regulators, will be rolled out gradually in Africa. "We believe that there should be a thoughtful, staged roll-out of this vaccine, particularly because it is important that we acquire more knowledge about where it really works the best," GlaxoSmithKline (GSK) Chief Executive Andrew Witty told reporters. Experts also need to build up a bigger database on safety, he added, since it is the first time a vaccine will have been launched in Africa without any history of use in developed countries.
Rhode Island to Mandate HPV Vaccine for All 7th Graders
Starting this fall, seventh-graders in all public and private schools will be required to get a vaccine that protects against a sexually transmitted virus linked to various genital cancers, especially cervical cancer in women. Students who fail to get the vaccine for HPV — or the human papillomavirus — will be precluded from attending school unless their parents seek an exemption for medical or religious reasons. Rhode Island becomes the third jurisdiction, including Virginia and Washington, D.C., to make the vaccine mandatory. Locally, some parents are already agitating against the vaccine, saying it's an intrusion by the government into private matters and that the vaccine's side effects can be serious. But Tricia Washburn, chief of the office of immunization for the Rhode Island Department of Health, said the vaccine has been thoroughly studied by the Centers for Disease Control, which monitors adverse outcomes, and no safety concerns were found. The Department of Health decided to make the vaccine mandatory, unlike most states, she said, because Rhode Island incorporates all CDC-recommended vaccines into the state's school immunization regulations.
The Hospitals That Do Best and Worst against Superbugs
While a hospital is supposed to be a sterile, safe place where sick people go to get better, thousands of patients each year actually end up sicker because of hospital-acquired infections. A new investigation from Consumer Reports looks into hospital infections to rate which hospitals do better or worse at protecting their patients from dangerous bugs. Each year, about 648,000 people in the United States develop infections during a hospital stay, and about 75,000 die with them, according to the Centers for Disease Control and Prevention. Many of these cases can be traced back to inappropriate antibiotic use, the very drugs that are supposed to fight infections. "Hospitals can be hot spots for infections and can sometimes amplify spread," Dr. Tom Frieden, director of the CDC, told Consumer Reports. "Patients with serious infections are near sick and vulnerable patients -- all cared for by the same health care workers sometimes using shared equipment." For the first time ever, Consumer Reports included data on MRSA and C. diff infections -- two of the most common and deadly "superbugs" in the U.S. – in their hospital ratings.
The Health IT Safety Center Roadmap: What’s Next?
On July 17, 2015, the Office of the National Coordinator for Health Information Technology (ONC) released the Health IT Safety Center Roadmap that lays a path forward for progress in the field of health information technology-related patient safety. The proposed Center focuses on two core objectives: “using health IT to make care safer, and continuously improving the safety of health IT.” It recognizes that achieving health IT safety requires continual evidence, education, and engagement from a variety of health care stakeholders.
What Is the ONC Proposing? Briefly, the Roadmap calls for creation of a new national, public-private entity — a trusted convener of a diverse set of stakeholders committed to developing a learning health system focused on using health IT to make care safer and continuously improving the safety of health IT. Participants in this center would collaborate to:
- identify solutions to address health IT-related safety events and hazards;
- devise methods of improving the identification and sharing of information on health IT-related safety events and hazards;
- collect and disseminate evidence on successful health IT safety interventions; and
- promote health IT safety education and competency of clinicians in appropriate and safe use of health IT
Senators Push Bill to Authorize EINSTEIN 3A, Shore Up 'Insufficient Cybersecurity Practices' Governmentwide
Leaders of the Senate Homeland Security and Governmental Affairs Committee introduced a bipartisan bill that would grant federal agencies clear legal authority in utilizing EINSTEIN, the Homeland Security Department's continuous diagnostics and monitoring system. According to background information (pdf)) HSGAC provided on the bill, Sens. Tom Carper (D-Del.) and Ron Johnson (R-Wis.) joined in drafting The Federal Cybersecurity Enhancement Act of 2015 to try to bring an end to the "insufficient cybersecurity practices" that have led to recent incidents like the Office of Personnel Management breaches. Two recent breaches at OPM put the personal records of 22.5 million in the hands of cyber criminals.
Feds Months Away from Broader Cybersecurity 'Sprint' Strategy Following OPM Breaches
More than two weeks after the so-called "cybersecurity sprint" wrapped up, resulting in some improved protections across federal agencies, the government is working on an overarching strategy that's still months away. In a July 31 blog post, Federal Chief Information Officer Tony Scott wrote that a team of more than 100 experts from across the government and private sector are reviewing federal cybersecurity policies, procedures and practices. The government implemented the sprint following the high-profile breaches at the Office of Personnel Management that resulted in the theft of personally identifiable information from millions of current, retired and prospective employees and contractors. Under the 30-day sprint, the Office of Management and Budget directed agencies to patch vulnerabilities, limit user access to authorized systems and improve authentication. For example, Scott wrote that federal agencies increased their use of strong authentication such as using a personal identity verification card for privileged and unprivileged users to 72 percent, from 42 percent.
ONC Grant Funding Opportunities Help Advance Interoperable Health IT, Leverage Community Best Practices and Train the New Health IT Workforce
ONC announced more than $38 million in grant awards to 20 organizations from 19 states across the country to further efforts toward achieving better care, smarter spending and healthier people. This will include closing health IT gaps and working together to further the health of individuals and communities. The grant programs are community and state-based initiatives that help advance health information sharing, enable community members to work together to improve population health, improve the interoperability of health IT systems and continue efforts to train and nurture the health IT workforce. All of this work is built upon accomplishments of earlier grants funded through the Health Information Technology and Clinical Health Act (HITECH). Like interoperability, the success of these programs is a priority but really only a means to an end. These programs and the communities participating in them will help us move toward a world in which health IT and interoperability enable better care and better health. The successes from the initial HITECH programs saw major accomplishments such as bringing query-based exchange to 37 states, creating a series of learning guides for doctors & health care organizations, and reaching the original Community College workforce goal with 19,773 graduates.
Prevention Task Force Recommends Depression Screenings for Pregnant Women, New Moms
One in seven women experience depression during pregnancy or the first year after giving birth, yet many may not realize it or report their concerns to clinicians. A new proposal by the U.S. Preventive Services Task Force could help change that. It recommends that all women who are pregnant or within a year of giving birth be screened for perinatal depression, as it’s called. The screening proposal is included as part of a broader recommendation to screen all adults for depression that the task force released this week for public comment. The task force proposal would update the current guidelines, adopted in 2009, which recommend depression screening in all adults if clinicians are available to address depression care. In the 2009 document, the task force didn’t review depression in pregnant and postpartum women and made no screening recommendation for them.
Expert Panel Withholds Support for Early Autism Screening
For years experts have urged physicians to screen infants and toddlers for autism in order to begin treatment as early as possible. But now an influential panel of experts has concluded there is not enough evidence to recommend universal autism screening of young children. The findings, from a draft proposal by the U.S. Preventive Services Task Force published Monday, are already causing consternation among specialists who work with autistic children.
“I was in a meeting when I read this, and I started feeling like I’d have chest pain,” said Dr. Susan E. Levy, a pediatrician who helped write the American Academy of Pediatrics guidelines urging universal screening of all babies, with standardized screening tools at both 18 and 24 months. “I would hate to see people stop screening.” Dr. David Grossman, a pediatrician and vice chairman of the U.S. Preventive Services Task Force, emphasized that the panel’s draft proposal was a call for more research and not intended to change practices. About half of all pediatricians routinely screen toddlers for autism. “This doesn’t mean ‘don’t screen.’ ” Dr. Grossman said. “It means there is not enough evidence to make a recommendation.”
Controversial Gene Therapy Might Help Women Have Healthy Children
For an estimated 12,000 American women of childbearing age, having a baby is a genetic game of Russian roulette. Due to a rare flaw in their eggs, their offspring run a significant risk of living short and painful lives, with bodies unable to make enough energy to grow properly. Genetic engineering might help such women have healthy children. But even as some countries consider such advances, the techniques are proving controversial. Genetic manipulation that involves combining material from the eggs of two different women was recently legalized in the United Kingdom. It is not allowed in the United States, where scientists want to start clinical trials and the Food and Drug Administration is weighing the issues involved in such technologies.
GE Healthcare to Spend $1 Billion to Train Health Workers
GE Healthcare is planning to spend more than $1 billion over five years on educational offerings meant to reach more than 2 million health professionals worldwide. The training is meant for physicians, radiologists, technologists, midwives, nurses, biomedical engineers, and more, and will include new clinical, product application, technical, and leadership training and education. Training could take place on-the-ground, online, and remotely. The spending builds in GE’s existing strategy of using education as a tool to boost its customer base.
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