A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
November 29, 2012
Less Support for Hepatitis C Testing for Baby Boomers
An influential advisory committee has given only lukewarm support to a government recommendation that all baby boomers be tested for hepatitis C. In a draft opinion, the United States Preventive Services Task Force said that clinicians may “consider offering” hepatitis C screening to adults born between 1945 and 1965. That falls short of the recommendation made in August by the Centers for Disease Control and Prevention that all adults in that age group should get a one-time test to see if they are infected.
Meningitis Toll Tops 500
The number of cases in the continuing fungal meningitis outbreak has reached 510, with 36 deaths, the CDC reported Nov 26th. The toll includes 496 cases of central nervous system infection, usually involving meningitis, and 14 cases of peripheral joint infections, the agency reported. The update is the first since Nov. 19, when the CDC reported 490 cases (including 12 joint infections) and 34 deaths.
HHS Releases Proposed ACA Insurance Regulations
Starting in 2014, the Patient Protection and Affordable Care Act will make it illegal for health insurance companies to discriminate against people who have pre-existing conditions, which HHS estimates affect some 129 million nonelderly Americans. In the proposed rule, health insurance issuers would generally be barred from denying coverage for such conditions, and individuals would have new special enrollment opportunities in the individual market when they have certain losses of other coverage. Under the regulation, insurance companies will be permitted to vary premiums within limits based on age, tobacco use, family size and geography. Health insurance companies will no longer be able to use factors such as pre-existing conditions, health status, claims history, gender and occupation as reasons to increase premiums.
Comment Period Now Open: Help Set the Stage for Meaningful Use Stage 3
Speak up now and help ONC’s Health Information Technology Policy Committee (HITPC) as they begin to develop meaningful use stage 3 recommendations that target a collaborative model of care with shared responsibility and accountability, and build upon previous meaningful use objectives.
The Request for Comment (RFC) [PDF- 313KB] for meaningful use stage 3 is broken into the following sections:
- Meaningful Use Objectives and Measures
- Quality Measures
- Privacy and Security
FDA Launches New Device Guidance Website
The FDA launched a new medical device guidance website, aiming to streamline the way the agency publishes and solicits comments on guidance documents developed by the Center for Devices & Radiological Health. The new site includes a docket for comments where stakeholders can offer suggestions, propose draft language and comment on the priority of topics for guidance during 2013.
After absorbing criticism for failing to immediately disclose a deadly superbug outbreak, officials at the National Institutes of Health have agreed to notify state and county officials of any potentially high-profile diseases or outbreaks, even those that do not pose an obvious public risk, county officials said.
The new agreement between NIH, Maryland and Montgomery County is scheduled to be finalized, an NIH spokeswoman said. The pact is designed to prevent the controversy spawned after an antibiotic-resistant strain of the bacterium Klebsiella pneumoniae spread throughout the 234-bed research facility in Bethesda.
Washington Hospital Reviewing Hundreds of Pap Tests After Lawsuit
The Washington Hospital is reviewing at least 500 Pap smear slides analyzed by its laboratory after a woman claimed in a lawsuit that one of the hospital's pathologists misread her tests for five consecutive years before she was diagnosed with cervical cancer, according to the attorney who filed the case.
While refusing to answer specific questions about the case, the hospital said in an emailed statement that it takes "these allegations very seriously." "Immediately upon learning of this complaint, the hospital consulted with independent experts to evaluate the claims at issue, and is working diligently to identify any patient safety concerns," the hospital in Washington, Pa., also said. "The Hospital is also cooperating with independent agencies to evaluate the quality of pathology services, and preliminary results have not identified any widespread deficiencies in PAP smear interpretation. In the event that patient safety concerns are identified or verified, the Hospital is prepared to follow up with individual patients and their physicians."
Among the groups investigating the allegation are the Pennsylvania Department of State, the federal Centers for Medicare and Medicaid Services, and accrediting organizations such as The Joint Commission and the College of American Pathology.
AMA Meeting: Standards Sought as Clinical Use of Gene Sequencing Speeds Up
Appropriate professional standards and regulation will help ensure that recent advances made in the use of genomic-based technologies benefit more patients, according to policies adopted at the American Medical Association Interim Meeting. In its action, the AMA House of Delegates recognized the utility of these genomic technologies and encouraged the development of standards to guide clinical use as well as best practices for the laboratories performing such tests. The AMA also will support regulatory and payment policies to enable doctors to use these diagnostic tools when clinically appropriate.
A New Prenatal Test for Spotting Genetic Issues is Less Invasive, but it’s Pricey
Three versions of this test, which can be performed as early as 10 weeks into a pregnancy, have come onto the market since December. Tens of thousands of women have used them, according to the companies that sell the tests. But they are not subject to regulation by the Food and Drug Administration, and questions have been raised about a technology whose accuracy and role are still being assessed. As a result, no major insurance company has yet agreed to cover the tests, whose list prices range up to $1,900.
With the new tests, fragments of fetal DNA extracted from the mother’s blood sample are checked for increased amounts of material from chromosomes 21, 18 and 13, a sign that the fetus carries three instead of the normal two copies of those chromosomes. In this case, more is not better. Having an extra copy of 21, a condition called trisomy 21, is the main cause of Down syndrome, while having a third copy of 18, a condition called trisomy 18, causes a less common disorder named Edwards syndrome. Trisomy 13 is also known as Patau syndrome. All three conditions are linked to serious developmental and medical problems.
Exome Sequencing: Potential Diagnostic Assay for Unexplained Intellectual Disability
Research findings confirming that de novo mutations represent a major cause of previously unexplained intellectual disability were presented at the American Society of Human Genetics 2012 meeting. Josep de Ligt, M.Sc., bioinformatician and Ph.D. student in human genetics at Radboud University Nijmegen Medical Centre in The Netherlands, also reported findings lending support to the use of exome sequencing, which deciphers over 21,000 protein-coding genes and not the entire human genome, as a diagnostic assay to determine whether one or more genetic mutations explain a patient’s intellectual disability.
The cause of intellectual disability, which represents a wide range of phenotypes, or observable biological characteristics, is unknown in at least 50% of patients. Most individuals with intellectual disability without a known cause are the only members of their families with the condition. Because the cause of their child’s cognitive impairment is unknown, parents are often baffled. The child with a cognitive disability is often an “isolated case without family history of the condition,” said de Ligt, adding that intellectual disability occurs in about 1% of the population.
A potential biomarker of the brain's neuroplasticity may predict improvements in symptoms and quality of life after a concussion, researchers said. In a single-center, case-control study, patients with mild traumatic brain injury (TBI) who had more abnormally high fractional anisotropy (FA) had fewer concussive symptoms and better quality of life a year after their injury than those who had less of the biomarker, according to Michael Lipton, MD, PhD, of the Albert Einstein College of Medicine in Bronx, N.Y., and colleagues. They reported their findings during a press briefing at the Radiological Society of North America meeting in Chicago.
Rapid TB Test Could Improve Treatment, Reduce Deaths
A rapid tuberculosis (TB) test could significantly improve treatment and reduce the number of deaths in Southern Africa, according to a study published online November 20 in PLOS Medicine. Nicolas A. Menzies, a PhD candidate in health policy at the Harvard School of Public Health in Boston, Massachusetts, and colleagues developed a calibrated, dynamic mathematical model to study the potential health and economic effect of implementing the Xpert MTB/RIF (Cepheid) test in Botswana, Lesotho, Namibia, South Africa, and Swaziland. They projected results for 10- and 20-year periods beginning in 2012.
Xpert is an automated DNA test that can identify TB and determine whether or not it is resistant to rifampin in just 2 hours. The World Health Organization has recommended it for use in those at high risk for multidrug-resistant TB (MDR-TB) and/or HIV-associated TB.
New Method Can Diagnose Malaria From a Single Drop of Blood or Saliva.
The researchers have developed a technology called REEAD (Rolling Circle-Enhanced Enzyme Activity Detection) - which makes it possible to diagnose malaria from a single drop of blood or saliva. This method is much more time-effective and cost-effective than current diagnostic methods, and can be performed by personnel who have no specialised training. It can therefore be used in low-resource areas without the use of expensive equipment, clean water or electricity. The ongoing fight against malaria is complicated by increasing problems with resistant Plasmodium parasites. In addition, several Plasmodium species (P. vivax and P. knowlesi) cannot be detected with the usual quick-test methods. The new REEAD-based method distinguishes itself from other quick-test methods because it can measure whether a given Plasmodium infection is resistant to drugs. The newly developed technology is also the only quick-test method that makes it possible to diagnose the less common malaria parasites (P. ovale, P. knowlesi and P. malariae) in addition to the most common Plasmodium parasites (P. falciparum and P. vivax).
Faster Diagnosis for Some Chronic Fatigue Syndrome Cases
For the first time, researchers have landed on a potential diagnostic method to identify at least a subset of patients with chronic fatigue syndrome (CFS), a complex disorder with no known definitive cause or cure. In a pilot study of six patients, scientists detected specific antibodies linked to latent Epstein-Barr virus reactivation in blood samples from people who had experienced classic CFS symptoms and responded to antiviral treatment. Control blood samples from 20 healthy people showed no such antibodies. The research team, led by scientists from Ohio State University and Oakland University William Beaumont School of Medicine, acknowledges that the number of patients is small. But the researchers say the study's power rests in their access to 16 months of blood samples for each patient - a collection allowing for an unprecedented longitudinal look at CFS. The researchers plan to move forward with development of a clinical laboratory test that can detect these antibodies in blood samples.
Detection of Early Markers of Epstein Barr Virus; the Diagnostic Value
Epstein-Barr virus (EBV) is the cause of infectious mononucleosis and a risk for serious disease in liver transplant recipients. Molecular tests that can identify early protein markers produced by EBV may have value for diagnosing active infection. The benefits of this diagnostic approach in patients with mononucleosis and in EBV-infected transplant patients are evaluated in an article published in BioResearch Open Access, a bimonthly peer-reviewed open access journal from Mary Ann Liebert, Inc., publishers.
An emerging tick-borne disease that causes symptoms similar to malaria is expanding its range in areas of the northeast where it has become well-established, according to new research presented at the annual meeting of the American Society of Tropical Medicine and Hygiene (ASTMH). Researchers from the Yale School of Public Health reported that from 2000 to 2008, cases of babesiosis - which invades red blood cells and is carried by the same tick that causes Lyme disease - expanded from 30 to 85 towns in Connecticut. Cases of the disease in Connecticut, where it was first reported in 1991, also have risen from 3 to about 100 cases per year.
Phlebotomy: Reducing Preanalytical Laboratory Sample Errors Through Educational and Technological Interventions
The educational program for nursing personnel is relevant and important as can be seen in the decrease of sample errors and the resulting quality improvement. The custom label system minimizes the potential oversight of forgetting to draw a tube, which happens frequently when operating without appointments, by printing the labels according to requested tests. Detection, identification, and monitoring of the error and implementing strategies to improve preanalytical quality reduces error numbers and thereby improves patient safety and health system outcomes.
Should Infectious Diseases in Dogs and Cats Be Monitored?
Most emerging infectious diseases of humans come from animals. International health agencies monitor these diseases, but they do so only for humans and livestock, not for companion dogs and cats. A new study recommends a global system is needed to monitor infectious diseases of companion dogs and cats. The study, led by Michael Day, Professor of Veterinary Pathology in the School of Veterinary Sciences at the University of Bristol and published online in Emerging Infectious Diseases, lists key infectious diseases that may be transmitted between dogs and cats and man ('zoonotic diseases'). It is well recognised that most of the major new diseases of mankind will have an animal origin and dogs and cats are a potential source of such 'emerging diseases'.
Thinking Clearly About Personality Disorders
For years they have lived as orphans and outliers, a colony of misfit characters on their own island: the bizarre one and the needy one, the untrusting and the crooked, the grandiose and the cowardly. Their customs and rituals are as captivating as any tribe’s, and at least as mystifying. Every mental anthropologist who has visited their world seems to walk away with a different story, a new model to explain those strange behaviors.
Now the Board of Trustees of the American Psychiatric Association will vote on whether to adopt a new diagnostic system for some of the most serious, and striking, syndromes in medicine: personality disorders.
69 Percent of US Primary Care Doctors Now Have Electronic Medical Records
Survey of 10 countries finds US Primary care doctors most likely to spend time dealing with insurance restrictions; Majority support fundamental health system change; All countries need to improve communication about patient care
Two-thirds (69%) of U.S. primary care physicians reported using electronic medical records (EMRs) in 2012, up from less than half (46%) in 2009, according to findings from the 2012 Commonwealth Fund International Health Policy Survey, published as a Web First online in the journal Health Affairs. Primary care physicians in the U.S. - the only country in the study without universal health coverage - stand out in the survey for reporting that their patients often cannot afford care (59%). By comparison, between 4 percent and 25 percent of physicians reported affordability problems for their patients in Norway (4%), the U.K. (13%), Switzerland (16%), Germany (21%), and Australia (25%). Moreover, more than half of U.S. doctors (52%) said insurance restrictions on their care decisions are a major time concern - by far the highest rate in the 10-country survey. U.S. physicians also were the most negative about their country's health system, with only 15 percent agreeing the health care system works well.
Slowly but surely, state health and human services agencies are recognizing the transformative potential of information technology, according to a report published by the American Public Human Services Association (APHSA) and Microsoft.
The survey, “A Promising Future for HHS Transformation – The Real Impact of IT System Modernization,” polled 67 agency program leaders from 35 states at various stages of modernizing their information technology systems, gauging the status of those who have implemented solutions for eligibility determination and benefit issuance, case management and online self-service – as well as those who had not yet modernized.
Seeing Health IT Through Patients' Eyes
The National eHealth Collaborative released a framework to guide the transition from provider-centered health IT to a system built around patients. The collaborative’s Patient Engagement Framework outlines five major phases from the perspective of patients: inform me, engage me, empower me, partner with me and support my e-community.
The “inform me” and “engage me” steps align with the first stage of “meaningful use” requirements. Health-care providers must demonstrate that they have achieved “meaningful use” of electronic health records to qualify for incentive payments under Medicare and Medicaid. Most providers either have or are attesting to Stage 1 meaningful use now. “Empower me” aligns with Stage 2 of meaningful use, in which EHR performance evaluation depends more heavily on patient engagement. Providers must begin meeting Stage 2 in 2014, and Stage 3 in 2016. “Partner with me” aligns with Stage 3 meaningful use.
Electronic Health Records Can Identify At-risk Untreated Patients and Lead to Better Preventive Care
In a new study, Northwestern Medicine researchers found that patients at high risk for cardiovascular disease (CVD) are more likely to receive a prescription for cholesterol-lowering medication, and to achieve lower long-term cholesterol levels, when doctors use electronic health records (EHRs) to deliver personalized risk assessments via mail. "It is important to get high priority preventive care messages to patients in a variety of ways," said Stephen Persell, MD, assistant professor of general internal medicine and geriatrics at Feinberg, and first author on the paper. "Sending a mailed message that depicts one's actual cardiovascular risk may lead some patients to action even though talking about treating cholesterol with their physician did not."
The paper was published in the Journal of General Internal Medicine.
Patient Identification Errors one of Health IT’s 2013 Concerns
Health IT data mismatches, often caused by mix-ups within electronic health record systems, will be a concern for patients and providers in 2013, according to a report released by the ECRI Institute. Technology is often to blame for such errors, with EHR system design a likely cause, though human error is still a factor in some cases.
Selecting the proper EHR system is the first step in reducing the number of data inaccuracies. Ensuring that only certified professionals can access an EHR system and interoperability with other EHR systems are two areas to consider when making an EHR selection. Providing only qualified people with access to patient data and organizing workflow by determining who is responsible for entering and updating data can cut down the number of data mix-ups
Matching DNA With Medical Records to Crack Disease and Aging
A massive research project in California is beginning to show how genes, health habits and the environment can interact to cause diseases. And it's all possible because 100,000 people agreed to contribute some saliva in the name of science. The project's goal is to find new ways to identify people at risk before they develop problems like heart disease, cancer and diabetes.
The saliva came from members of Kaiser Permanente's health plan in Northern California. "We sent them a little plastic kit that looks sort of like a large contact lens case," says Cathy Schaefer, an epidemiologist and executive director of Kaiser's research program on genes, environment and health. Before long, she says, people had mailed in 100,000 saliva samples.
Biometric card developer SmartMetric has developed a way to store electronic health records on a key ring USB device activated by patients' fingerprints. SmartMetric has announced a biometric key ring as an alternative method to running enterprise software on PCs to store and access electronic health records. A developer of biometric credit and ID cards, SmartMetric launched the KeyringMedicalRecords device on Nov. 14. The storage unit allows users to maintain portability while not requiring software on a PC, according to the company.
OIG: Fraud Crackdown Nets Record-Breaking Recoveries
The Office of Inspector General is on its way to setting a record in recoveries of about $6.9 billion this fiscal year, according to its semiannual report submitted to Congress. With "significant progress over the past year," according to Inspector General Daniel Levinson, OIG reported $923.8 million from audits and $6 billion from investigations, as well as $8.5 billion in estimated savings resulting from legislative, regulatory or administrative actions from OIG's recommendations.
CDC: Youths Make Up 1 in 4 New HIV Cases
Teens and young adults now account for more than a quarter of the new cases of HIV identified in the United States annually, and a clear majority of those cases involve young gay or bisexual men, the federal government said in a major new survey. Of the nearly 48,000 new HIV cases identified in the United States in 2010, the latest year for which complete data are available, more than 12,000 involved teens and young adults, the Centers for Disease Control (CDC) found in its latest report. About 72 percent of these new HIV cases in younger adults occurred in young men who are gay or bisexual, according to the CDC report. The report comes as officials, researchers and activists gear up for World AIDS Day on Dec. 1, with U.S. and global organizations releasing a stream of reports about the state of the pandemic.
AMA Meeting: Delegates Adopt Physician Employment Principles
The autonomy of the rising number of employed physicians ought to be respected, and patient care should come before the financial interests of employers, according to principles on physician employment adopted in November at the American Medical Association Interim Meeting. The principles, contained in an AMA Board of Trustees report the House of Delegates adopted, cover potential flash points in physician-employer relationships such as conflicts of interest, contracting, payment agreements, peer reviews, performance evaluations and medical staff-hospital relations.
The house’s move comes as the proportion of physicians with an ownership stake is falling. In 2000, 57% of the nation’s 682,470 practicing physicians owned at least a part of their medical practices. In 2013, that figure is expected to be 36%, according to an analysis of data from the AMA and MGMA-ACMPE done by the consulting firm Accenture.
Medicare Payment Changes Draw Fire
Neurologists in Boston and nationwide are objecting to a plan that would pay them less for certain diagnostic tests, a change meant to cut Medicare costs and direct more money to primary care physicians whose pay is widely seen as inadequate even before they take on more work under the national health care overhaul. The neurologists are asking federal regulators to reconsider the plan and argue that the cuts, made under a provision of the Affordable Care Act, could undermine patient care and limit access to neurology services. The debate highlights the short-term pain and pressure expected from changing the way health care is paid for, a process certain to produce winners and losers.
Dr. Joseph E. Murray, who opened a new era of medicine with the first successful human organ transplant, died on Monday in Boston. He was 93. He died at Brigham and Women’s Hospital, where he performed his first transplant, said Tom Langford, a hospital spokesman. The cause was complications from a stroke he suffered last Thursday, Mr. Langford said.
Dr. Murray’s groundbreaking surgical feat came in 1954, when he removed a healthy kidney from a 23-year-old man and implanted it in the man’s ailing identical twin. Dr. Murray went on to pioneer techniques that over the years changed the lives of tens of thousands of patients who received new kidneys, hearts, lungs, livers or other organs after their own had failed. In 1990, he was awarded the Nobel Prize in Physiology or Medicine.
Europe to Pump $26M into Plant Molecular Science Consortia
Europe has launched a new funding call that will fuel new plant genomics and molecular biology research with an expected €20 million ($25.7 million), with the aim of backing international research consortia to address major agricultural and climate-related problems.
The new effort, the European Research Area Network for Coordinating Action in Plant Sciences (ERA-CAPS), will expand on the earlier ERA-PG (Plant Genomics) program, which has awarded €55 million to fund 41 projects since it began in 2006, according to the European Commission.
Concern at Outsourced Clinical Trials in Developing World
Few drug companies have robust measures to ensure outsourced clinical trials in developing countries are safe and ethical, an independent report says. Most provided no evidence of exerting real influence over the way the trials were conducted by contractors, the latest Access to Medicine Index said. However, the report also praised firms for stepping up their efforts to provide affordable medicines. Published every two years, it ranks the world's 20 biggest drug companies.
HIV Tests Should Be Routine for Most, Canada AIDS Experts Say
The push for routine screening for HIV infections is gathering heft. Recently, the U.S. Preventive Services Task Force -- which advises the U.S. government and doctors on preventive medicine -- proposed that everyone ages 15 to 64 be offered an HIV test by doctors. The advice, which isn’t finalized, would replace older recommendations by the task force that HIV tests be offered just to those who are at high risk for catching the virus based on their sexual behavior, as well as all pregnant women.
Now two Canadian doctors are calling for similar routine screening in their country.
Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.
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