A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
December 17, 2015
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- FDA Issues Draft Ebola Guidance for Blood Centers
- CDC Debuts New Tools for Testing and Assessing Risk for HIV
- Is Lab Testing the ‘Wild West’ of Medicine?
- Diabetes: Too Much Testing?
- Prostate Cancer Test Is More Reliable if Done Twice
- Clinical Trials Are Subjecting Cancer Patients to Too Many Biopsies, Study Finds
- Molecule Clears Alzheimer's Plaques in Mice
- Arthritis Predicted 16 Years Before Disease Takes Hold Using New Test
- Mayo Clinic Researchers Uncover Six Possible Protein Biomarkers for Bipolar Disorder
- Task Force: Screen All Teens, Adults at Risk for Syphilis
- First Dengue Fever Vaccine Approved by Mexico
- FDA Approves First Recombinant von Willebrand Factor to Treat Bleeding Episodes
- Survey: Healthcare Organizations Lack Confidence in Secure Data Sharing
- Electronic Health Records, Data Analytics Integral to Payment Reform
- ONC Offers 'Corrections and Clarifications' of 2015 Final Rule
View Previous Issues - Healthcare News Archive
The FDA has issued a draft guidance for comment purposes with recommendations for facilities that collect blood and blood components in the event of ongoing outbreaks of the Ebola virus. The draft guidance calls for additional screening and measures when the CDC declares an outbreak in one or more countries. The agency's recommendations include indefinite deferral for people who had the virus, and an eight-week deferral for people who have traveled to or lived in an affected area or had close contact with someone who was or might be infected with the virus. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM475072.pdf
CDC Debuts New Tools for Testing and Assessing Risk for HIV
Officials with the Centers for Disease Control and Prevention (CDC) unveiled a new national HIV testing campaign and the beta version of an online tool to assist individuals assess and reduce their risk of acquiring or transmitting HIV. The announcements came at the 2015 National HIV Prevention Conference in Atlanta, Georgia. CDC officials are also piloting a new comprehensive online HIV Risk Reduction Tool, which lets people get customized information on behaviors that place them at risk for HIV and strategies to reduce their risk. The tool helps people determine how best to protect themselves and their partners. “Both of these efforts are designed to help people take control of their health, make informed choices, and reduce their risk for getting and transmitting HIV,” Jonathan Mermin, MD, director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention said in a press release about the announcements.
Is Lab Testing the ‘Wild West’ of Medicine?
Largely unregulated industry comes under FDA scrutiny; lab-developed test providers fight back
The Food and Drug Administration sees lab-developed tests as the Wild West of medicine, citing examples of inaccurate tests it claims put patients at risk. The agency is trying to toughen its supervision next year after largely leaving the business alone for decades and focusing most of its oversight on traditional testing methods. Lab-developed test providers are fighting back. They say their tests are accurate and even lifesaving. Industry officials say heightened regulation could stifle innovation. The FDA said it found problems with certain tests for heart disease, ovarian cancer, Lyme disease, whooping cough and autism. Because lab-developed tests can cost as much as roughly $15,000 per test, bad results also could waste millions of dollars a year. And when multiple labs offer tests to detect the same medical condition, it is impossible for doctors to know which tests are the most reliable. For example, the significance of blood tests for genes that can signal breast cancer varies widely, says Dr. Otis Brawley, medical director of the American Cancer Society.
Building the Foundations for Cancer Genomic Analysis for Research and Clinical Diagnostics
An eye-opening article from the International Cancer Genome Consortium (ICGC) was published in the prestigious journal Nature Communicationsxc. It lays a foundation for the coming era of research in cancer genomics. The project, led by the Centro Nacional de Analisis Genómico (CNAG-CRG) and the German Cancer Research Center (DKFZ) is the result of an effort to create reliable standards to obtain accurate results in the detection of somatic mutations, which are a hallmark of cancer genomes. As whole genome sequencing of cancer genomes is increasingly being used as a clinical tool, full understanding of the variables affecting sequencing analysis output quality is required. David Jones, a Senior Scientist at the DKFZ who co-led the study, commented that "as the latest technological advances in cancer genome analysis become more widely available to support personalized cancer medicine, it is vitally important that rigorous quality testing is applied to ensure accuracy and consistency of results. We hope that our study can provide a framework for this process, to help researchers in providing the best possible analysis of patients' samples."
Diabetes: Too Much Testing?
Most adults with controlled diabetes get tested too often
Six out of ten adults with controlled type 2 diabetes receive too many hemoglobin A1c (HbA1c) tests, leading to waste and the possibility of overtreatment with hypoglycemic drugs. In a retrospective analysis of almost 32,000 patients, researchers found that HbA1c testing frequency was excessive in 5% of cases and more frequent than guidelines suggest in 55% of cases. Though all patients had good glycemic control at baseline, more insulin or glucose-lowering drugs were given to 13% of patients who were tested excessively, 9% who were tested too frequently, and 7% who were tested according to the guidelines (P<0.001). In total, 8.4% of patients were given additional treatment, according to author Rozalina McCoy, MD, at the Mayo Clinic in Minnesota. McCoy and colleagues published their findings in The BMJ. "Ultimately, patients and doctors should question the value of routine tests and test bundles, increasingly built as defaults within protocols and algorithms to improve compliance with quality metrics and performance in those metrics," they wrote.
Prostate Cancer Test Is More Reliable if Done Twice
A team of researchers in Ottawa, Canada, have discovered that unnecessary biopsies can be reduced by 60 per cent
A test for prostate cancer is more reliable if done twice, researchers have found, which could lead to a dramatic fall in unnecessary diagnostic surgery. The prostate-specific antigen (PSA) test has been used to help screen for prostate cancer for more than 20 years but it has been found to be unreliable, leading to calls for it to be abandoned. Now a team of researchers in Ottawa, Canada, have discovered that if it is repeated then its reliability increases, reducing unnecessary biopsies by 60 per cent. The research team reviewed the medical records of 1,268 men who had an abnormal (high) PSA test result and were evaluated at the Ottawa Regional Cancer Assessment Centre between 2008 and 2013. In 25 percent of these men, the second PSA test came back normal. Only 28 percent of men with conflicting test results underwent a biopsy compared to 62 percent of men who had two abnormal test results, representing a 60 percent reduction in biopsies. In addition, only three percent of men with conflicting test results who had a biopsy were diagnosed with cancer within the year, compared to 19 percent of men who had two abnormal tests, suggesting that the second normal test is important. The study is by The Ottawa Hospital and the University of Ottawa.
Clinical Trials Are Subjecting Cancer Patients to Too Many Biopsies, Study Finds
Cancer patients in clinical trials across the United States are undergoing a slew of expensive, invasive biopsies with no clear benefits, according to an analysis published in the Journal of Clinical Oncology. Patients involved in clinical trials for experimental drugs often get extra biopsies meant to search for biomarkers — broadly speaking, any type of biological measure of health or illness. The additional biopsies are often mandated by the National Cancer Institute or by the drug company sponsoring the trial, with a goal of using biomarkers to track how the medication affects patient health. But when researchers looked at 72 clinical trials in which cancer patients had extra biopsies, they found that only 12 turned up any significant biomarkers. And none led to data on optimal drug doses for patients.
Waiting to Exhale
Clinical Breath Tests Advance Slowly Towards Adoption
A single exhaled breath contains hundreds, if not thousands, of volatile organic compounds (VOCs), some of which may be specific biomarkers of disease. Numerous researchers are now exploring this possibility in the hopes of developing non-invasive, easy-to-use, and cost-effective point-of-care (POC) breath tests that rapidly detect a variety of diseases. In recent years, breath test researchers have reported several significant findings. For example, Hossam Haick, PhD, a professor of chemical engineering at Technion–Israel Institute of Technology in Haifa, identified a distinctive “breath print” for gastric cancer, and demonstrated that a nanoarray apparatus he and his colleagues are developing accurately discriminates between both gastric cancer patients and control subjects, as well as high- and low-risk premalignant lesions. Similarly, Michael Phillips, MD, founder and CEO of Menssana Research in Newark, New Jersey, has provided evidence that Menssana’s rapid POC breath test (BreathLink) accurately identifies women with breast cancer, and distinguishes women who have abnormal mammograms from those with normal results. Philips and his colleagues also reported that BreathLink accurately identifies subjects with active pulmonary tuberculosis (TB), and they are collaborating with Colorado State University (CSU) researcher Diane Ordway, PhD, to develop a breath test that detects early TB infection.
Biocept, Baylor to Develop Estrogen Receptor Liquid Biopsy Tests
Biocept announced a collaboration with Baylor College of Medicine to develop blood-based tests using Biocept's circulating tumor cell and circulating tumor DNA assay platforms. Specifically, the partners aim to detect mutations in the estrogen receptor gene (ESR1) in order to guide treatment for women with breast cancer, and hope to develop assays to identify the emergence of mutations that confer resistance to endocrine therapies like Tamoxifen.
AABB and A2LA Form Laboratory Accreditation Partnership
Providing laboratories with a three-for-one assessment opportunity to streamline their accreditation processes, the AABB and the American Association for Laboratory Accreditation (A2LA) have partnered to provide a joint accreditation program. A2LA is an independent nonprofit accrediting body that assesses competence of laboratories as well as proficiency testing providers and other entities. AABB provides accreditation programs for entities involved in transfusion medicine, cellular therapies, and patient blood management. The joint program will assess laboratories according to AABB accreditation standards, International Organization for Standardization 15189:2012, and the Clinical Laboratory Improvement Amendments (CLIA) requirements. In a statement announcing the partnership, AABB’s Chief Executive Officer Miriam A. Markowitz asserted this “combined clinical laboratory accreditation program, drives operational excellence and is an important step for ensuring that clinical laboratories are prepared to provide the safest products, treatments and services for patients.”
Molecule Clears Alzheimer's Plaques in Mice
A molecule can clear Alzheimer's plaques from the brains of mice and improve learning and memory, Korean scientists have found in early tests. Exactly how it gets rid of the abnormal build-up is not understood. The small Nature Communications study hints at a way to tackle the disease even once it is in full swing, dementia experts say. But there is no proof the same method would work in people - many more years of animal trials are needed first. Scientists, reason that preventing or removing the plaques might help, and many drug candidates are in development. Some drugs still being tested appear to stop the plaques from forming - but that is if it taken early enough, before the disease has advanced. However, the South Korean researchers believe they may have found a molecule, called EPPS that could work even if plaques have already formed.
Arthritis Predicted 16 Years before Disease Takes Hold Using New Test
Scientists at Oxford University have developed a blood test that can predict a person’s chances of developing rheumatoid arthritis up to 16 years before it takes hold. Rheumatoid arthritis (RA) occurs when some proteins are altered during inflammation in a process called citrullination, causing an immune response that turns antibodies on themselves. The researchers tested for antibodies that target citrullinated tenascin-C (cTNC), a protein which is found in high levels in the joints of people with the disease. Results from 2,000 patients found that testing for the antibodies could diagnose the disease in around 50 per cent of cases, including some cases not picked up by existing tests. It is also 98 per cent accurate at ruling out RA, according to lead researcher Dr Anja Schwenzer.
Mayo Clinic Researchers Uncover Six Possible Protein Biomarkers for Bipolar Disorder
Researchers from the Mayo Clinic have uncovered a half-dozen proteins that might serve as biomarkers for bipolar disorder. Mayo Clinic's Mark Frye and his colleagues examined 272 proteins in a cohort of nearly 300 people with bipolar I depression, bipolar II depression, unipolar depression, and healthy controls. They found six proteins that differed between people with bipolar I depression and controls, suggesting that these proteins might be markers for the condition, as they reported in Translational Psychiatry. "The potential of having a biological test to help accurately diagnose bipolar disorder would make a huge difference to medical practice," Frye, Mayo's head of psychiatry and psychology, said in a statement. "It would then help clinicians to choose the most appropriate treatment for hard-to-diagnose individuals."
One-Step Tumor Detection from Dynamic Morphology Tracking on Aptamer Grafted Surface
A team of researchers from the University of Texas at Arlington (UT-Arlington) in Texas, USA has demonstrated a novel cancer cell detection method based on real time cell behavior tracking on engineered surfaces. A synthetic RNA molecule is coated on chip surface to identify cancer cells. The otherwise "calm and quiet" cells on this surface show interesting dancing behavior when their membrane receptors are matched to the surface RNA molecules. The behavior is quantified using interesting image processing techniques. Cancer cells are shown to demonstrate significantly different behavior than regular healthy cells. This phenomenon has potential to detect cancer in a tabletop setup thus leveraging doctors to perform frequent and economic tests with faster results and better disease prediction. The report appears in the December 2015 issue of the journal TECHNOLOGY.
Cancer Treatments May Need to Be Tailored to Each Tumor
Cancers are diverse, and that makes them extremely difficult to treat. What worked stunningly for one person might fail utterly for another. What worked for a tumor in the brain probably won't work on a cancer of the liver. Scientists are trying to outwit tumors by coming up with tailored treatments like the immunotherapy drug used to successfully treat former President Jimmy Carter. But it's very hard to figure out how to find the right drug for a specific patient. A paper published in Nature Communications suggests one thing that might help is identifying the astonishing mix of cells inside a tumor. It's not just cancer in there. Tumors can swallow up cells around them and grow into composites of malignant and healthy tissue.
MITF Gene Variant Associated With Increased Melanoma Risk, High Nevi Count
A rare functional variant in the MITF gene was associated with increased melanoma risk, especially in patients with multiple primary melanoma, and high nevi count, according to study results recently published in JAMA Dermatology. The researchers conducted a case-control study of 531 patients at the Melanoma Unit of Hospital Clinic of Barcelona, using TaqMan probes to genotype MITF p.E318K in all patients. There were 271 patients with multiple primary melanoma (MPM) affecting p16INK41 (wild-type p16INK4A), 191 probands from melanoma-prone families without mutations affecting p16INK4A and 69 patients with mutated p16INK4A.
A New Gold Standard to Improve Cancer Genome Analysis
When various labs are asked to investigate cancer cell genomes in search of mutations, their results can sometimes show significant variations, a team of scientists from the International Cancer Genome Consortium (ICGC) found out in a worldwide interlaboratory test. The researchers have now provided a sequencing data record as a “gold standard” as well as guidelines for bioinformatic evaluation in order to create uniform worldwide standards in the search for cancer-relevant mutations. The study was led by scientists from the German Cancer Research Center (DKFZ) in Heidelberg and the Spanish National Center for Genome Analysis (CNAG-CRG) in Barcelona.
The investigators found significant variations both in sequencing and evaluation results in some of the cases. Only 40 percent out of one thousand small mutations, which each affected the exchange of only a single DNA base, were identified uniformly by all participating teams. The outcome for small DNA losses and insertions was even less favorable: Only a single one out of 337 of these genomic changes was identified by all of the centers.
Sequencing Study Tracks Roots of TB Emergence to East Africa
An international team led by investigators in the UK and Spain has garnered genetic evidence that the tuberculosis-causing pathogen Mycobacterium tuberculosis originated in Africa. As they reported in Current Biology, the researchers did genome sequencing on 66 M. tuberculosis complex (MTBC) isolates from Ethiopia and compared them with hundreds of previously sequenced MTBC isolates from around the world. Based on the nature and diversity of the Ethiopian M. tuberculosis lineages, the team proposed that the bug has an East African origin — results that appear to contradict the so-called virgin soil theory which posits that TB was introduced by Europeans to previously unaffected populations in Africa.
‘Hijacking’ and Hibernating Parasite Could Alter Behaviour
Melbourne researchers have discovered how a common parasite hijacks host cells and stockpiles food so it can lie dormant for decades, possibly changing its host’s behaviour or personality in the process. The findings could lead to a vaccine to protect pregnant women from Toxoplasma infection, which carries a serious risk of miscarriage or birth defects, as well as drugs to clear chronic infections in people with compromised immune systems, such as cancer patients.
'Suicide' Gene Therapy Kills Prostate Cancer Cells
A new gene therapy technique is able to modify prostate cancer cells so that a patient's body attacks and kills them, U.S. scientists have discovered. The technique causes the tumour cells in the body to self-destruct, giving it the name 'suicide gene therapy'. Their research found a 20% improvement in survival in patients with prostate cancer five years after treatment. A cancer expert said more research was needed to judge its effectiveness. The study, led by researchers from Houston Methodist Hospital in Texas, appears to show that this 'suicide gene therapy', when combined with radiotherapy, could be a promising treatment for prostate cancer in the future.
Diagnostics with Birefringence
ETH researchers led by Raffaele Mezzenga have developed a new diagnostic method. It is based on Birefringence, the ability of substances to change the polarisation state of light. With this method, doctors around the world can easily, rapidly and reliably detect malaria, Ebola or HIV to name only a few. What sounds almost like science fiction has now become reality. The research group led by Raffaele Mezzenga, Professor of Food and Soft Materials, has recently published a scientific paper in which it introduces a new rapid test that can detect not only malaria parasites but also viruses such as HIV or Ebola, diverse bacteria or biomarkers, like glucose or cholesterol.
Synthetic Long Reads Identify Diverse Bacterial Species in Human Gut Microbiome
To examine bacterial diversity in the gut microbiome, researchers from Stanford University have turned to a next-generation sequencing method that uses synthetic long reads. The method allowed them to identify bacterial species that could not be seen using short-read sequencing. The Stanford researchers, who published their results today in Nature Biotechnology, found previously uncharacterized bacterial strains and uncovered a greater-than-expected diversity. "The bacteria are genetically much more heterogeneous than we thought," senior author Mike Snyder said in a statement.
Short read sequencing is typically used to study bacteria because of its high throughput. But often, the shorter reads are not able to accurately identify all the bacterial strains present in a sample or assess the diversity of strains. Many bacteria cannot be cultured, so metagenomic sequencing has proven to be a good method to identify and characterize previously unknown microbes.
NIH to Provide Additional Funding for Clinical Validation of Cancer Diagnostics
The National Institutes of Health has announced that it will allocate further funding to support the refinement of molecular cancer diagnostics that have shown promise in their initial development but require additional refinement before they can be tested in National Cancer Institute-supported clinical trials. NIH is seeking revisions of currently active research grants that require additional funding to clinically validate existing assays using human specimens so that they may be developed into full-fledged molecular diagnostics for use in clinical trials, it said. NCI staff also will proactively help investigators meet the necessary requirements in order to mitigate these issues.
Task Force: Screen All Teens, Adults at Risk for Syphilis
Proposed recommendation dovetails with surge in U.S. cases of the sexually transmitted disease
All adults and teens at increased risk for syphilis should be screened for the sexually transmitted disease, a U.S. Preventive Services Task Force draft recommendation says. The recommendation complements a 2009 task force recommendation that all pregnant women be screened for syphilis. Rates of the disease in the United States are on the rise, with nearly 20,000 cases of the earliest stages of syphilis reported in 2014, the highest since 1994. "Given the rising rates of syphilis infection, clinicians should focus on screening people at increased risk," task force member Dr. Francisco Garcia said in a task force news release. Garcia is director and chief medical officer of the Pima County Department of Health in Tucson, Ariz., and a professor of public health at the University of Arizona.
First Dengue Fever Vaccine Approved by Mexico
A dengue fever vaccine developed by the French pharmaceutical giant Sanofi has been approved for use by Mexico, the first approval in the world for any vaccine for the disease, which afflicts tens of millions of people around the world and is becoming an increasing threat. Sanofi said in a news release that the vaccine, which it is calling Dengvaxia, was approved by Mexico’s Federal Commission for the Protection against Sanitary Risk for prevention of dengue in people 9 to 45 years old living in endemic areas. “We are making dengue the next vaccine-preventable disease,” Olivier Charmeil, executive vice president for vaccines at Sanofi, said in an interview. But it is still uncertain how widely the vaccine will be deployed, both in Mexico and other countries, because of limits to its effectiveness and national budgets.
FDA Approves First Recombinant von Willebrand Factor to Treat Bleeding Episodes
The U.S. Food and Drug Administration approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD). Vonvendi is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with VWD. VWD is the most common inherited bleeding disorder, affecting approximately 1 percent of the U.S. population. “Patients with heritable bleeding disorders should meet with their health care provider to discuss appropriate measures to reduce blood loss,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Vonvendi provides an additional therapeutic option for the treatment of bleeding episodes in patients with von Willebrand disease.”
Flu Shots for Hospital Workers Save Lives
The Department of Veterans Affairs should lead the way and mandate influenza vaccination for its health-care workers.
Seasonal flu caused as many as 55,000 deaths in 2014, according to the Centers for Disease Control and Prevention (CDC). It may surprise you to know that some of these deaths are likely the result of health-care workers transmitting the influenza virus to their patients. Hospitals have begun requiring their staff to get vaccinated, or wear masks if they cannot or will not get vaccinated. The mandates work: A CDC survey this year showed that hospitals, physician offices, long-term care facilities and other clinics with mandatory vaccination achieved 96% coverage for their workers, compared with 44% coverage in institutions that don’t. A 2014 CDC study showed that health-care worker vaccinations reduce patients’ risk of influenza-like illness by 42%. The CDC has long recommended annual influenza vaccination for all health-care personnel. And the U.S. Department of Health and Human Services, as part of its Healthy People initiative, wants 90% of health-care workers vaccinated by 2020.
Disease Sleuths Analyze Google Searches to Stop Infections
With sexually transmitted diseases on the rise, researchers at the University of Illinois at Chicago think they might have a powerful new weapon to fight their spread: Google searches. The company behind the Web's leading search engine has quietly begun giving researchers access to its data troves to develop analytical models for tracking infectious diseases in real time or close to it. UIC is one of at least four academic institutions that have received access so far, along with the Centers for Disease Control and Prevention, Google said. Researchers can mine Google data to identify search terms that spiked during previous upticks in a particular disease. Then, researchers can measure the frequency of those searches in real time to estimate the number of emerging cases. For instance, a jump in gonorrhea might coincide with more people searching "painful urination" or other symptoms. "If this works, it could revolutionize STD surveillance," said Supriya Mehta, an associate professor of epidemiology at the UIC School of Public Health.
HIV Prophylaxis Could Benefit 1.2 Million: CDC
About 1.2 million people in the U.S. are at "substantial risk" of HIV and could benefit from taking a daily pill to prevent the infection, the CDC said. Analysis suggests that about 25% of men who have sex with men and 20% of those who use nonprescription injection drugs would benefit from so-called pre-exposure prophylaxis (PrEP), the agency said in a Vital Signs report published online in Morbidity and Mortality Weekly Report.
Many of those people are not being offered the measure, in many cases because their medical provider simply isn't aware of the option, according to Anne Schuchat, MD, the agency's principal deputy director. A recent survey suggested that 34% of primary care providers are not aware of PrEP as a way to prevent HIV, she told reporters in a telephone briefing, even though the FDA approved it in 2012 and the CDC issued formal guidance on how to use it last year. "Doctors need more prep about PrEP," Schuchat said.
Survey: Healthcare Organizations Lack Confidence in Secure Data Sharing
According to a new survey, the demand for access to health data is outpacing the ability of organizations to ensure patient privacy. A survey conducted by Privacy Analytics, a de-identification technology vendor, found that more than two out of three healthcare organizations lack complete confidence in their ability to share data without putting patients’ privacy at risk. The survey, conducted in collaboration with the Electronic Health Information Laboratory, a group that conducts theoretical and applied research on the de-identification of health information, also indicated that despite organizations’ lack of confidence, data sharing activities continue to grow. The survey, called The State of Data Sharing for Healthcare Analytics 2015-2016, polled 271 professionals with various levels of seniority in their organizations, from the C-suite level to managers and employees.
Electronic Health Records, Data Analytics Integral to Payment Reform
EHRs and data analysis will play an ever increasing and evolving role beyond the Meaningful Use program as Medicare moves to new health care delivery payment models. "A different infrastructure will be needed for reform. It depends on data not just in one EHR but a new longitudinal measure," said Kelly Cronin, Director of ONC's Office of Care Coordination, speaking at the American Bar Association Health Law Section's Annual Washington (D.C.) Health Law Summit. In order to transition to newer payment models based on quality and value, data analytics becomes "key," added attorney Sidney Welch, with Kilpatrick, Townsend & Stockton, also speaking at the Summit.
ONC Offers 'Corrections and Clarifications' of 2015 Final Rule
In order to 'eliminate confusion and ambiguity' in its 500-plus page 2015 Edition EHR certification criteria, the Office of the National Coordinator for Health IT has added corrections to the Federal Register to help vendors better understand the final rule. The notice corrects cross-references and citation omissions and gives further clarification for the 2015 Edition Health Information Technology Certification Criteria, 2015 Edition Base Electronic Health Record Definition and ONC Health IT Certification Program Modifications first published in October, according to ONC. Read the new clarifications here.
When It Comes to Mining Healthcare Big Data, Including Medical Laboratory Test Results, Optum Labs Is the Company to Watch
Mayo Clinic has tapped Optum Labs’ huge data set to fuel research suggesting diabetes management can be too aggressive among those diabetics who don’t have problems controlling their glucose level. Optum Labs’ data is also being mined to investigate dozens of research initiatives, including a major fight against Alzheimer’s disease. These projects provide a glimpse into the growing role of big data in healthcare. Because more than 70% of a typical patient’s permanent medical record consists of clinical laboratory test data, pathologists and medical laboratory scientists have a stake in the growth of big-data analytics, which are a core component in healthcare’s journey toward personalized medicine.
DirectTrust Predicts the End of Meaningful Use
Interoperability, "freed" health data, patient engagement and data security among trends to watch in 2016
Next year will be another one of "momentous forward movement" when it comes to interoperability in the healthcare sector, DirectTrust predicts. The industry alliance of Direct exchange network users released a report on 2016 healthcare trends in the interoperable exchange of information. "In the world of electronic health information exchange, we're on track for ... increased adoption by providers and greater interoperability between federal and state agencies with private-sector providers. We'll also see, finally, patient and consumer participation in the use of electronic health information exchange," David Kibbe, M.D., president and CEO of DirectTrust, said in an announcement.
Health IT Research: Improving User Interface to Improve Patient Outcomes
Further research is needed to establish best practices for integrating patient-reported information into practice through innovative health IT, according to AHRQ-funded research. Part of a journal issue that examined clinical decision support and the concept of usability, “Evidence into Action: Improving User Interface to Improve Patient Outcomes,” includes AHRQ-funded studies that highlight lessons learned by developing and testing health IT interfaces, such as websites, apps, and dashboards. The tools examined in this special issue were purposed to improve patient care. Select to access the special issue of eGEMS (Generating Evidence and Methods to Improve Patient Outcomes).
Future Physicians Need Telemedicine Education, Training
The rise of telemedicine will require that medical education cover new skills to teach future physicians's how to use it effectively and ensure proper quality of care, according to a viewpoint published in the Journal of the American Medical Association. The authors, from the University of California, San Francisco School of Medicine, cite potential advantages to telemedicine, such as allowing clinicians to see the home of a child with cystic fibrosis to assess environmental risk factors, and talk to family members.They write that because of the promise telemedicine holds for care, "educators across the continuum of medical education must help prepare physicians to engage in the safe and effective use of telemedicine."
NCBI Hackathons Aim to Develop Standard Computational Pipelines for Bioinformatics Tasks
The National Center for Biotechnology Information is organizing a three-day hackathon to be held early next year that will bring groups of investigators together to develop tools for analyzing next-generation sequencing data in the context of specific research questions. The hackathon will take place Jan. 4-6 at the National Library of Medicine. In this iteration of the hackathon, teams will develop pipelines for automated epitope analysis from TCR clones; verifying structural variant data using public information; and for enabling network coalescence of SNPs. They will also build a Bioconductor module to import data from SRA; a tool for deriving quaternary interactions of clinically relevant mutations from protein structure; and on creating an interface for metadata sorting, according to the NCBI.
The Biomedical Research Enterprise at a Crossroads
The U.S. biomedical research enterprise is in serious trouble. While the National Institutes of Health (NIH)—the country’s main funding source—still boasts an impressive $30 billion annual budget, the agency’s spending power has declined more than 20% since 2004. This belt-tightening after a period of surging funding has thrown the system into disarray, with institutions and principal investigators grappling for grants and PhD candidates and post-doctoral fellows struggling to find permanent, satisfying positions. Some observers have gone so far as to suggest that the funding shortfall is threatening America’s prowess in biomedical research.
Quest to Manage Barnabas Health’s Hospital Laboratories
Quest Diagnostics, which has been extending itself more into the operation of hospital laboratories in recent years, has just inked a deal to manage the labs owned by the largest hospital operator in its home state. The Barnabas Health system, which operates hospitals in New Jersey, has hired Quest to manage many of its on-site laboratories, the two organizations announced earlier this week. Quest will manage Barnabas-owned labs at six different hospital sites, primarily in Northern New Jersey.
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