A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
December 12, 2013
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The Road Toward Fully Transparent Medical RecordsForty years ago, Shenkin and Warner argued that giving patients their medical records “would lead to more appropriate utilization of physicians and a greater ability of patients to participate in their own care.” At that time, patients in most states could obtain their records only through litigation, but the rules gradually changed, and in 1996 the Health Insurance Portability and Accountability Act entitled virtually all patients to obtain their records on request. Today, we're on the verge of eliminating such requests by simply providing patients online access. Thanks in part to federal financial incentives, electronic medical records are becoming the rule, accompanied increasingly by password-protected portals that offer patients laboratory, radiology, and pathology results and secure communication with their clinicians by e-mail. One central component of the records, the notes composed by clinicians, has remained largely hidden from patients. But now OpenNotes, an initiative fueled primarily by the Robert Wood Johnson Foundation, is exploring the effects of providing access to these notes. Beginning in 2010, at Beth Israel Deaconess Medical Center (which serves urban and suburban Boston), Geisinger Health System (in rural Pennsylvania), and Harborview Medical Center (Seattle's safety-net hospital), more than 100 primary care doctors volunteered to invite 20,000 of their patients to read their notes securely online.
What's a Normal Lab Result for a Transgender Patient?Transgender patients on hormone therapy should have their own laboratory reference ranges, researchers say. "We realize that since information regarding this population is lacking in medical education, many providers may never have considered the unique challenges that accompany their care," Dr. Tiffany K. Roberts from Emory University School of Medicine in Atlanta, Georgia, told Reuters Health. "While the interpretation of many laboratory values does not change for transgender individuals undergoing hormone therapy, there are a number of important values for which the interpretation does change," Dr. Safer said.
ACP Advises Against CKD Screening; ASN ObjectsIn a new clinical practice guideline, the American College of Physicians (ACP) recently recommended against screening for chronic kidney disease (CKD) in asymptomatic adults without risk factors (Ann Intern Med 2013;159:1–13). The guideline committee based this recommendation, rated as weak with low-quality evidence, on an extensive scientific literature review dating back to 1985. “The potential harms of all the screening tests—false positives, disease label, and unnecessary treatment and associated adverse effects—outweigh the benefits,” said ACP President Molly Cooke, MD, in a statement.
New Technique Diagnoses Cancer From Bodily FluidsHarvard researchers contributed machine learning techniques to improve UCLA diagnostic tool. A team of researchers from Harvard University and the University of California, Los Angeles, have demonstrated a technique that, by measuring the physical properties of individual cells in body fluids, can diagnose cancer with a high degree of accuracy. When cytopathologists screen for cancer in pleural effusions, they perform a visual analysis of prepared cells extracted from the fluid. Preparing cells for this analysis can involve complicated and time-consuming dyeing or molecular labeling, and the tests often do not definitively determine the presence of tumor cells. As a result, additional costly tests often are required. The method used to assess the cells in the UCLA–Harvard study, developed previously by the UCLA researchers, requires little sample preparation, relying instead on the imaging of cells as they flow through microscale fluid conduits.
ADHD: Brain Iron May Be MarkerLow Fe levels in the brain may signal the presence of attention-deficit/hyperactivity disorder (ADHD), researchers reported here. In a small study of children and adolescents with ADHD, those who'd never taken any drugs for their condition had significantly lower levels of brain iron as seen on magnetic correlation field (MFC) imaging compared with controls and with those being treated with drugs for the condition, according to Vitria Adisetiyo, PhD, of the Medical University of South Carolina, and colleagues.
3D Mammography 'Significantly Increases Breast Cancer Detection'Regular mammograms are crucial in helping to prevent deaths as a result of breast cancer. But new research from the Perelman School of Medicine at the University of Pennsylvania suggests that 3D mammography is significantly more effective for breast cancer detection and leads to fewer patient recalls. The findings were presented at the annual meeting of the Radiological Society of North America (RSNA).
BD Diagnostics Receive FDA Clearance for StaphSR AssayBD has received FDA clearance to market the BD MAX™ StaphSR Assay for use on the fully-automated BD MAX™ System. The assay, with eXTended Detection Technology, accurately detects Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA directly from nasal swabs, including mecA dropout mutants and new strains of MRSA that may not be detected by other assays.
PathGroup Expands Footprint with Two New Dedicated LaboratoriesPathGroup, one of the largest private providers of pathology services in the United States, announced that it has opened two new state-of-the-art facilities dedicated exclusively to molecular and cytology testing. The new laboratories are adjacent to PathGroup’s current laboratory in Nashville, Tenn. The two additional testing sites have the capability to perform molecular assays for oncology, including Next-Generation Sequencing (NGS), as well as infectious disease and women’s health diagnostics. The new space also includes a CLIA-validation laboratory for test development and implementation.
23andMe Suspends Health-Related Data Interpretation for New CustomersDirect-to-consumer testing firm 23andMe has decided to comply with the US Food and Drug Administration's wishes and discontinue providing health-related genetic data interpretation services to new customers. In a Nov. 22 warning letter, signed by Alberto Gutierrez, director of FDA's Office of In Vitro Diagnostics and Radiological Health, the agency asked 23andMe to "immediately discontinue marketing" its Personal Genome Service "until such time as it receives FDA marketing authorization for the device." The agency gave 23andMe 15 days to respond to its letter and explain why the company had failed to garner FDA's okay for its Personal Genome Service.
23andMe to Refund Some Customers' MoneyThe Mountain View-based 23andMe has decided to offer refunds to customers who recently paid $99 to have the company analyze a portion of their DNA and calculate their risk of developing about 250 medical conditions. The move comes less than two weeks after the U.S. Food and Drug Administration ordered 23andMe to stop marketing its consumer-oriented DNA test kit and analysis service, saying the company had failed to prove that they were safe, effective and reliable. The FDA expressed concern that some customers would make potentially life-threatening medical decisions based on 23andMe's controversial look at some of the DNA found in a person's saliva. Such analysis involves using chips from Illumina of San Diego.
Myriad Genetics Sues LabCorpMyriad Genetics has filed a lawsuit against Laboratory Corporation of America alleging infringement of 11 US patents covering its BRCA 1 and 2 testing franchise. The suit, filed in the US District Court for the District of Utah, Central Division, followed LabCorp's launch of its Comprehensive BRCAssure BRCA 1/2 Analysis for identifying patients with BRCA mutations who are at risk of developing breast, ovarian, and other cancers. LabCorp said the analysis includes full gene sequencing of BRCA1/2 genes and duplication/deletion testing, with a variant of unknown significance rate of less than 5 percent.
Partnership to Address Shortages in Lab TechniciansThe Northwest Illinois Collaborative (NWIC), an organization composed of hospitals in the northwest Illinois region, and Weber State University are announcing a new program to help address critical shortages in medical laboratory technicians. The program will allow employees at the five hospitals involved to take classes online to earn degrees from Weber State in medical laboratory science. The NWIC includes Rockford Memorial Hospital and OSF Saint Anthony Medical Center in Rockford, FHN in Freeport, Katherine Shaw Bethea Hospital in Dixon and CGHMC in Sterling. NWIC President Julie D. Mann, MBA, said: “According to the U.S. Bureau of Labor Statistics, 12,400 graduates will be needed annually to staff the nation’s medical laboratories. However, on a national basis, less than half of the necessary laboratory personnel are graduating.
Medicare Gets Lower Rates for Lab Services, Finds New StudyA new study from Avalere Health refutes government claims that commercial plans pay lower rates for lab services than Medicare. Instead, the study found that Medicare rates are almost always lower than average rates paid by private plans. The study, commissioned by the American Clinical Laboratory Association, included 2012 prices paid by non-government health plans in over 450 metropolitan statistical areas in the United States for 56 million covered lives. For example, commercial payers paid an average of $20.26 for a complete blood count (CBC). Medicare's price is almost half at $11.02.
Researchers Sequence Mitochondrial Genome From 400,000-Year-Old HomininMitochondrial genome sequences from a 400,000-year-old hominin found in a cave in Spain indicate that the ancient individual belonged to a mitochondrial lineage most closely related to that of the Denisovans — archaic Neandertal relatives that roamed eastern Eurasia. An international team, led by Max Planck Institute for Evolutionary Anthropology Director Svante Pääbo, used specialized DNA extraction and enrichment methods to sequence a nearly complete mitochondrial genome from the ancient individual's thigh bone — believed to be the oldest non-permafrost sample successfully sequenced so far.
Study Suggests RNA From Single Nuclei Sufficient for SequencingA team from the J. Craig Venter Institute, the Salk Institute for Biological Studies, and elsewhere has shown that it's possible to glean gene expression and transcript sequence information from individual nuclei by sequencing the miniscule amounts of messenger RNA present in the organelles. The approach, described in the early online version of the Proceedings of the National Academy of Sciences last month, hinges on the same sorts of complementary DNA synthesis methods already used for single-cell RNA sequencing. By applying such approaches to single nuclei from mouse neural progenitor cells or cells from a mouse brain sample, researchers showed that they could generate RNA sequence profiles similar to those found in individual cells or bulk samples from the same cell types.
Radioimmunotherapy Shows Promise for Curing HIV InfectionNew York researchers have found that radioimmunotherapy (RIT) offers a strategy for curing human immunodeficiency virus (HIV) infection, according to a study highlighted at the RSNA 2013 meeting. Highly active antiretroviral therapy (ART) keeps the number of viral particles in a patient's bloodstream very low, greatly improving the prognosis for those infected with HIV. But despite the therapy's success in reducing the burden of HIV in the body, dormant infected cells remain, blocking the possibility of a permanent cure. Lead author Ekaterina Dadachova, PhD, of Albert Einstein College of Medicine, and colleagues investigated whether radioimmunotherapy could destroy remaining HIV-infected cells in blood samples of patients treated with antiretroviral therapy. The team applied radioimmunotherapy to blood samples from 15 HIV patients treated with highly active antiretroviral therapy at the Einstein-Montefiore Center for AIDS Research.
Research Can Help Throw Mosquitoes off the ScentWhy does the mosquito change its track and fly towards skin? How does it detect our skin? What are the odors from skin that it detects? And can we block the mosquito skin odor sensors and reduce attractiveness? Recent research done by scientists at UC Riverside can now help address these questions. They report in Cell that the very receptors in the mosquito’s maxillary palp that detect carbon dioxide are ones that detect skin odors as well, thus explaining why mosquitoes are attracted to skin odor – smelly socks, worn clothes, bedding – even in the absence of CO2. The new finding – that the CO2-sensitive olfactory neuron is also a sensitive detector of human skin – is critical not only for understanding the basis of the mosquito’s host attraction and host preference, but also because it identifies this dual receptor of CO2 and skin-odorants as a key target that could be useful to disrupt host-seeking behavior and thus aid in the control of disease transmission.
Scientists Use Weather Forecasting Methods to Predict Flu Season PeakBy adapting techniques used in weather forecasting, scientists were able to predict the timing of last year's flu season up to more than two months before its peak. The team of scientists at Columbia University's Mailman School of Public Policy carried out their study in 108 cities across the country. Their findings were published in the journal Nature Communications. "Having greater advance warning of the timing and intensity of influenza outbreaks could prevent a portion of these influenza infections by providing actionable information to officials and the general public," said lead author Jeffrey Shaman, in a statement.
Diseases on the Move Because of Climate ChangeValley Fever is one of multiple diseases experts say are spreading in part because of climate change. They include a brain-eating amoeba showing up in northern lakes that were once too cold to harbor it and several illnesses carried by ticks whose range is increasing. Each year, more than 150,000 people in Arizona, California, Nevada, New Mexico and Utah are infected, and Arizona and California have the most cases, according to the CDC. The incidence of laboratory-confirmed cases rose from 2,265 in 1998 to more than 22,000 in 2011.
HIV Virus Returns After Cure Hope RoseBoston researchers are reporting the return of the HIV virus in two patients who had become virus-free after undergoing bone marrow transplants, dashing hopes of a possible cure that had generated widespread excitement. The rebound of the virus shows its persistence, and that it can hide in places in the body where it’s hard to find, said the lead scientist, Dr. Timothy Henrich of Brigham and Women’s Hospital. But he said the team has gleaned significant clues from the cases for designing next-generation treatments to battle the virus, which causes AIDS.
H7N9 Cannot Infect Humans Easily: StudyThe H7N9 bird flu virus has not yet acquired the changes needed to infect humans easily but it would not be wise to dismiss its potential risk, according to a U. S. study published in the journal Science. In contrast to some initial studies that had suggested that H7N9 poses an imminent risk of a global pandemic, the new research found, based on analyses of virus samples from the outbreak in China earlier this year that H7N9 is still mainly adapted for infecting birds. "Luckily, H7N9 viruses just don't yet seem well adapted for binding to human receptors," said senior author Ian Wilson, professor at The Scripps Research Institute (TSRI), a California- based medical research facility, in a statement.
Drugs Need Labels for NewbornsFederal legislation encouraging the study of drugs in pediatric patients has resulted in very few labeling changes that include new infant information, according to a study by Matthew Laughon, of the Univ. of North Carolina at Chapel Hill, and colleagues. Study findings, published in JAMA Pediatrics, indicate 11 (46 percent) of the 24 neonatal labeling changes made clear the drug was approved for use in neonates on the basis of safety and effectiveness. Researchers then found that most of the studied drugs were not used in neonatal intensive care units (NICUs), with 13 (46 percent) of the 28 drugs studied in neonates not used and eight (29 percent) of the drugs used in fewer than 60 neonates.
NYC may Mandate Flu Vaccines for All Daycare, Preschool StudentsA flu shot may soon be required for all New York City daycare and preschool kids. New York City health officials will decide Wednesday whether to adopt a proposal that would require all children under 5 who are attending one of these childcare facilities to receive a flu shot by Dec. 31 of each year, before flu season peaks. “A lot of people have a misconception that the flu is just like the common cold and nothing that needs to be worried about,” Dr. Jay Varma, deputy commissioner of the New York City Department of Health and Mental Hygiene, told CBS News. “In fact, flu is common and can be very serious for children under the age of 5,” he said. Varma estimates the mandate would prevent more than 20,000 cases of flu in young kids.
More Helpful Fatty Acids Found in Organic MilkWhole milk from organic dairies contains far more of some of the fatty acids that contribute to a healthy heart than conventional milk, scientists are reporting. The finding, published in the journal PLOS One, is the most clear-cut instance of an organic food’s offering a nutritional advantage over its conventional counterpart. Studies looking at organic fruits and vegetables have been less conclusive. Drinking whole organic milk “will certainly lessen the risk factor for cardiovascular disease,” said the study’s lead author, Charles M. Benbrook, a research professor at Washington State University’s Center for Sustaining Agriculture and Natural Resources. The research was largely funded by Organic Valley, a farm cooperative that sells organic dairy products. But experts not connected with the study said the findings were credible — though they noted that the role of milk in a healthy diet and the influence of fatty acids in preventing or causing cardiovascular disease are far from settled.
Report: VA Doesn't Adequately Protect Patients From Error-prone DoctorsPatients at Department of Veterans Affairs (VA) hospitals do not have adequate protection from doctors with a history of subpar treatment, according to a new report released by the Government Accountability Office (GAO). Of the four unnamed VA hospitals inspected by the GAO, none were in full compliance with all required procedures for peer review of patient care that leads to adverse outcomes, according to the report. In addition, inspectors found the VA failed to pursue several cases that potentially required disciplinary action.
Report: Physician Quality not Disclosed in Most StatesWhen it comes to providing consumers with easily accessible information about physician quality, a report out gave most states grades of ‘D’ or ‘F,’ often because they compile data only about primary care doctors, not specialists. Washington state and Minnesota were the only states that got an A from the Health Care Incentives Improvement Institute, a nonprofit group that designs programs aiming at boosting health care quality and affordability. California received a ‘C,’ and the rest of the states got either ‘D’s or ‘F’s. The report scored states on several factors, including the percentage of doctors they rated, whether those ratings included information about patient outcomes and consumer experiences and how easy it was to find them through an Internet search.
- A decline in the smoking rate, down from 21.2% of the adult population in 2012 to 19.6%. Seventeen states had significant drops in smoking, the largest being in Nevada, Maryland, Oklahoma, Kansas and Vermont.
- A drop in physical inactivity, defined as not doing any physical activity outside work for 30 days, down from 26.2% of the adult population in 2012 to 22.9% in 2013. The prevalence of physical inactivity varies from a high of 31.4% in Arkansas to a low of 16.2% in Oregon.
- A leveling off of the obesity epidemic as the percentage of adults who are obese — defined as roughly 30 or more pounds over a healthy weight — holds steady.
Specialists Notch Victory in New CMS Rule on Quality ReportingMedicare has agreed to allow specialist medical societies to determine the quality measures physicians will report when the new reporting system goes into effect on Jan. 1. The rule represents a major victory for the specialty societies, which had protested a common set of quality measures that many said favored primary care and family physicians over specialists. CMS in 2015 will begin imposing penalties on physicians who fail to report to one of these new "qualified clinical directories," which will satisfy requirements for participating in the agency's Physician Quality Reporting System.
ONC Creates Safety Guide for Providers Using HITThough the use of health information technology has the potential to improve patient care, the risks it poses prompted the Office of the National Coordinator for Health Information Technology at HHS to create a safety guide for providers. Developed by the not-for-profit ECRI Institute under an ONC contract, the publication—How to Identify and Address Unsafe Conditions Associated with Health IT (PDF) —provides guidance directed at healthcare and patient-safety organizations for identifying, monitoring and reporting on unsafe conditions related to health IT and especially electronic health records. That report, along with the ONC's Health IT Patient Safety Action and Surveillance Plan (PDF) , released in July of this year, draw attention to the need for more reporting of health IT errors and safety events.
10 Key Recommendations That Will Shape the Next Generation of HIEThe Workgroup for Electronic Data Interchange (WEDI) Foundation, a leading authority on the use of Health IT to improve healthcare information exchange, in partnership with industry leaders, has released the 2013 WEDI Report. The culmination of a nine-month public-private effort with more than 200 subject matter expert volunteers, the 2013 WEDI Report will serve as a new roadmap for Health IT over the next decade.
Key Report Areas of Recommendation
The 2013 WEDI Report identifies four critical areas of focus:
- Patient Engagement:
- Payment Models:
- Data Harmonization and Exchange:
- Innovative Encounter Models:
How Carolinas HealthCare Uses Quality Patient Data to Boost Disease Management"Most electronic health records were designed to replicate paper charts, without much thought to what could we do with the data once it is available electronically or how it could be used for population analytics," Dulin says. Analyzing integrated clinical, claims and administrative data enables the institution to better track outcomes and provide valuable feedback to clinicians to improve care. "Data integration can help providers ensure that we're developing and deploying best practices for population health," says Allen Naidoo, vice president of advanced analytics at Carolinas HealthCare. "This offers us the ability to make more informed decisions for patient care."
Hospitals Expected to Press Devicemakers, EHR Vendors to Make Their Products 'Talk'The typical hospital bed in an intensive-care unit is surrounded by as many as a dozen medical devices that monitor the patient, track blood pressure and heart rate, dispense medications and perform other vital functions. Many of the devices have the capability to transmit data they gather directly to the patient's electronic health record. For example, an “interoperable” infusion pump that gathers data about when a patient received fluids or insulin could transmit that data to the patient's EHR, preventing medication errors and creating a detailed record of the patient's clinical treatments and how the patient responded to medications. Experts say that would improve quality of care and lower costs.
Report: HIPAA is a Hindrance to Health Care Info SharingThe primary law safeguarding the privacy of personal medical information is an impediment to the use of big data in improving health care for the individuals it is intended to protect, according to a report from the Bipartisan Policy Center. The Washington, D.C., think tank characterized the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as too far-reaching and too "often misunderstood, misapplied and over-applied in ways that may inhibit information sharing unnecessarily."
Every Saudi's Choice to Have Genetic Code Mapped to Transform the Kingdom's HealthcareSaudi Arabia's national funding agency, and Life Technologies Corporation (NASDAQ:LIFE) announce The Saudi Human Genome Program – a national research project to study the genetic basis of all disease in the Kingdom and throughout the Middle East and use the findings to offer the ultimate personal care in Saudi Arabia. Through a network of an initial 10 genome centers across Saudi Arabia, the ambitious program using the Ion Proton™ DNA sequencer, will focus on sequencing 100,000 human genomes over the next five years to study both normal and disease-associated genes specific to the Saudi population, with five further genome centers to be created in the future. This genomic variant data will be fully analyzed and used to create a Saudi-specific database that will provide the basis for future development of personalized medicine in the Kingdom and represents the most comprehensive effort to identify the disease-causing genes for the population of a country and Arab peoples.
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