A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
December 6, 2012
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CDC Workgroup Publishes Guidelines for NGS-based Clinical Tests
A workgroup led by the US Centers for Disease Control has published guidelines for laboratories developing clinical tests based on next-generation sequencing.
The Next-generation Sequencing: Standardization of Clinical Testing (Nex-StoCT) workgroup, which included researchers from the CDC, clinical laboratories that have already developed sequencing-based tests, industry representatives, and representatives from the College of American Pathologists and the Centers for Medicaid and Medicare Services, published their guidelines in Nature Biotechnology earlier this month.
The guidelines address issues of validation, quality control, proficiency testing, and reference materials that are specific to next-generation sequencing technology. According to Ira Lubin, who leads the genetics team at the CDC, separate guidelines for clinical next-gen sequencing are necessary because such tests have the potential to be much more complex than other types of diagnostic testing, even Sanger sequencing, and current guidelines and regulations do not adequately address those complexities.
Additional Contamination Identified in Medical Products from New England Compounding Center
As part of the ongoing investigation of the multistate outbreak of fungal meningitis and other infections, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) continue to test medical products from the New England Compounding Center (NECC) in Framingham, Mass. CDC and FDA are reporting additional microbial contamination identified in NECC products.
- CDC and FDA have identified additional microbial contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC.
- These include bacteria known as Bacillus, and fungal species including Aspergillus tubingensis, Aspergillus fumigatus, Cladosporium species, and Penicillium species.
Improving Lab Reports
A limited number of studies have shown that improved formatting and templates can boost the quality of lab reports, but not many have evaluated physicians' use of enhanced reports or the impact of these reports on care management and outcomes. Recently, researchers at ARUP Laboratories examined how often clinicians took advantage of enhanced graphical reports available online (J Pathol Inform 2012;3:26). The research follows-up on a pilot project ARUP began in 2009 that gives clinicians access to special supplemental reports for certain tests. For the most part, such reports could not otherwise be transmitted using current lab information systems and electronic health records (EHRs). For physician access, ARUP offers a link and passcode in the footnotes of the standard version of results for these tests.
Supreme Court to Decide Whether Human Genes can be Patented, Could Reshape Medical Research
The Supreme Court announced it will decide whether companies can patent human genes, a decision that could reshape medical research in the United States and the fight against diseases like breast and ovarian cancer. The justices’ decision will likely resolve an ongoing battle between scientists who believe that genes carrying the secrets of life should not be exploited for commercial gain and companies that argue that a patent is a reward for years of expensive research that moves science forward
In 2010, a federal judge ruled that genes cannot be patented. U.S. District Judge Robert Sweet said he invalidated the patents because DNA’s existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body or the information it encodes. But the federal appeals court reversed him in 2011, saying Myriad’s genes can be patented because the isolated DNA has a “markedly different chemical structure” from DNA within the body. The Supreme Court threw out that decision and sent the case back to the lower courts for rehearing. This came after the high court unanimously threw out patents on a Prometheus Laboratories, Inc., test that could help doctors set drug doses for autoimmune diseases like Crohn’s disease, saying the laws of nature are unpatentable. But the federal circuit upheld Myriad’s patents again in August, leading to the current review. The court likely will hear the case in the early spring and rule before the end of the summer.
Court: Off-Label Drug Marketing Is 'Free Speech'
A decision by a federal appeals court this week could have a dramatic impact on the marketing of prescription drugs in America, potentially affecting patient care and everything from TV advertising to future government prosecutions which, in the past, had yielded billions of dollars in settlements, doctors and attorneys said. "This risks taking us back to an era when people could promote snake oil without restrictions – a situation I would hate to see," said Richard Deyo, MD, a professor of family medicine at Oregon Health and Science University.
Like the Citizens United case, the ruling by the prestigious U.S. Court of Appeals for the Second Circuit in New York, involved the right of commercial free speech, applying it to the complicated world of pharmaceutical industry promotion of prescription drugs. How wide-ranging the decision becomes likely will depend on whether it gets to the U.S. Supreme Court, attorneys said.
As Congress Tackles Deficit, Medicare Reimbursement and Workforce Training Endangered
As policymakers work to avert the fiscal cliff, laboratory professionals should be aware that among the priorities is some sort of fix, most likely temporary, to prevent the SGR-related cuts to the Medicare Physician Fee Schedule. But as policymakers work on these issues, pathologists and other laboratory professionals should understand that Congress is looking for areas of the federal budget where it can find savings. ASCP and its allies have identified Congressional reform of the Stark Self-Referral Law’s in-office ancillary services exception as one potential area for savings; however, we should all keep in mind that Congress has, in the recent past, considered imposing a co-pay, or cutting the Clinical Laboratory Fee Schedule, as another way to address the budget deficit.
New Test Helps Predict Viability of Pregnancy
A single progesterone measurement is a useful tool for predicting nonviable pregnancies after inconclusive ultrasound assessments in women who present with pain or bleeding early in their pregnancy, according to a new meta-analysis. The results of previous studies evaluating the accuracy of progesterone levels in predicting pregnancy viability have been conflicting. To help make sense of these findings, researchers analyzed 26 cohort studies involving 9436 women with a spontaneous pregnancy of less than 14 weeks of gestation to determine the accuracy with which a single progesterone measurement can discriminate between a viable and nonviable pregnancy.
Sputum PCR for TB Detection
Annual PCR-based screening of sputum for tuberculosis may reduce the prevalence of the disease, and drug-resistant forms of the disease, in prisons in the former Soviet Union, a new study in PLOS Medicine says. Technology Review's Susan Young notes that TB rates in such prisons are among the highest in the world. "These prisoners are 10 times more likely than the general population to have the disease and extremely likely to have a drug-resistant form of TB.
Cancer-related Chromosomal Changes Detected by Blood-based DNA Sequencing
Researchers from Johns Hopkins Kimmel Cancer Center and elsewhere have demonstrated that they can directly detect cancer-related chromosomal alterations in patient blood samples by sequencing cell-free DNA without prior knowledge of alterations present in the actual tumor.
Empire Genomics Licenses First Known DNA Biomarker for Multiple Myeloma
Empire Genomics announced it has acquired an exclusive license for patent pending novel genomic biomarkers from Emory University for use in developing a molecular diagnostic test that could help satisfy a large unmet medical need in determining ideal therapeutic treatment for multiple myeloma patients. . The team is embarking in a phase II biomarker driven clinical trial using this technology to validate its power to predict outcomes in new generations of MM drugs.
Cognoptix Licenses Alzheimer’s Test From UC San Diego
Acton medical device company Cognoptix has licensed technology from the University of California at San Diego and developed into a test for the early detection of Alzheimer’s disease. The company, formerly known as Neuroptix, said it has used the technology, which it has exclusive license to, and developed a non-invasive eye-scanning test to detect Alzheimer’s disease in patients.
PEPFAR to Buy Additional 150 Rapid TB Testing Devices
PEPFAR will purchase up to 150 rapid tuberculosis (TB) Xpert testing devices and cartridges to test about 450,000 people for TB, "addressing a need to improve diagnoses of drug-resistant strains of disease, and to identify the disease in HIV-positive people in sub-Saharan Africa and Myanmar, the Office of the Global AIDS Coordinator announced", the Center for Global Health Policy's "Science Speaks" blog reports. "The investment is part of an ongoing effort," according to the blog, which notes, "The announcement of the program's added investment in the Cepheid Xpert tests, following the pre-World AIDS Day release of PEPFAR's blueprint for creating an AIDS-free generation backs the plan's stated purpose of applying evidence-based approaches and scientific advances to confront the global HIV epidemic"
Repeat Testing Common Among Medicare Patients
In a new study, up to half - or more - of older adults on Medicare who had a heart, lung, stomach or bladder test had the same procedure repeated within three years. Those tests typically aren't supposed to be routinely repeated, researchers said. For some of them, such as echocardiography and stress tests for heart function, there are recommendations specifically against routine testing. "What we were struck by is just how commonly these tests are being repeated," said Dr. H. Gilbert Welch, lead author of the report from the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, New Hampshire. "Either these patients continually develop new problems or there are doctors who routinely repeat tests." Extra testing can burden the health care system with costs and may lead to incidental findings and unnecessary treatment for patients, Welch told Reuters Health.
Ferris State's New Grand Rapids Laboratory Aims to Fill Skills Gap in Michigan's Medical Industry
Inside Ferris State University’s newly renovated molecular diagnostics lab, students are learning the skills that administrators say will make them a perfect fit for clinical laboratories in West Michigan and beyond. Located on the campus of Grand Rapids Community College, students at the lab are learning the techniques needed to use molecular technology to screen patients before organ transplants, detect genetic disorders and infectious diseases, and determine therapy for genetic disorders. It’s administrators hope that Ferris students will master the techniques and fill a demand – expressed by hospitals and medical employers around the country – for clinical laboratory workers, trained in the burgeoning field of molecular medicine, Ferris said. “We’ve heard from people within the field that their labs are looking for students with this certification and who have an education in molecular diagnostics,” said Jonathan Karnes, the program’s coordinator. “There’s a need in the job market for students with this type of degree.”
FDA, Medical Device Industry Form Research Partnership
The Food and Drug Administration said it has formed a partnership with the medical device industry aimed at speeding the development and review of new device products. The nonprofit organization, called the Medical Device Innovation Consortium, will collaborate with patient support groups, academia, foundations and the Centers for Medicare and Medicaid Services to improve the process for bringing medical devices into the marketplace. The move comes as device makers push the FDA to speed up the review of devices, while advocacy groups contend the agency is doing too little to protect consumers.
NIH Provides $573,000 to 23andMe for Three Projects
23andMe said it has received $573,000 in funding from the National Institutes of Health to support three projects using the Mountain View, Calif.-based company's web-based research platform.
The first grant will go toward genome-wide associated studies aimed at discovering genetic factors affecting allergic disease risk, assessing gene-environment interactions, and treatment responses. 23andMe's research cohort, it said, includes more than 25,000 individuals with one or more allergies; more than 8,000 patients diagnosed with asthma; and more than 5,000 patients with eczema. More than 100,000 individuals will be used as controls for the study.
Another grant will be used by the company to investigate error rates from next-generation sequencing technologies with the goal of defining data quality metrics and technical specifications to support 23andMe's sequencing-based Personal Genome Service.
The third project seeks to develop tools to build out 23andMe's database.
Piedmont Hospital in Atlanta Begins Public Cord Blood Donations
Cells in the umbilical cords of newborns are now used to treat several forms of cancer and other illnesses. Until now, most parents have had to pay thousands of dollars if they wanted to store their baby’s cells in a private bank. Now, several Atlanta hospitals are offering free public cord blood donation. Stem cells in cord blood can be used to treat children and adults with illnesses including leukemia, lymphoma and sickle cell disease.
Get to Know the Bacteria and Viruses That Call Your Body Home
Are you willing to take a close look at yourself for science? A really, really close look? A team of scientists in the Bay Area is inviting citizen scientists to join them in a quest to create the largest database of human microbiomes in the world. The human microbiome is the ecosystem of microorganisms such as bacteria and viruses that live on and in your body. If that makes you feel squeamish, get over it. Your body is an ecosystem, providing a home for trillions of microscopic organisms. In fact, your body has more of these microorganism cells than human cells. And you need them to live. The microbiome mapping project, called UBiome, is still getting off the ground. Earlier this month, the scientists behind it turned to the crowd-funding website Indiegogo to solicit funds. If they get the funding they need, they hope to start shipping human microbiome sampling kits out by May.
Genome Sequencing for Babies Brings Knowledge and Conflicts
Genome sequencing deciphers an individual's entire genetic code. The price of doing this has been dropping quickly, raising the possibility that sequencing can become more common than ever before. That includes the possibility of sequencing all babies when they're born. Sequencing an individual's genome at birth would enable doctors to screen for far more genetic conditions than they do now. The hope is that it would catch more rare genetic conditions early, and help doctors prevent more complications and many deaths.
"Instead of screening for currently something like 30 conditions, it would allow you to screen for hundreds, if not thousands, [of conditions] at birth," says Dr. Alan. "One could imagine a day where knowing someone's entire genome sequence at birth, you could really begin to think about structuring their health care, their dietary choices, their exercise choices ... early in life, in a way that would have an impact on truly lifelong health," Guttmacher says.
But this idea is also raising a lot of concerns.
Source: : http://www.npr.org/
Proteins Expressed by Human Cytomegalovirus Revealed
New findings reveal the surprisingly complex protein-coding capacity of the human cytomegalovirus, or HCMV, and provide the first steps toward understanding how the virus manipulates human cells during infection. The genome of the HCMV was first sequenced over 20 years ago, but researchers have now investigated the proteome - the complete set of expressed proteins - of this common pathogen as well.
NFL Brain Study Involves Former High School Players
John Mackey and Ollie Matson, Pro Football Hall of Famers, are among 33 deceased NFL players diagnosed in a new study with a brain disease linked to concussions. But the study also reports early-stage cases some who only played high school football. The authors say that sounds an alarm that must be heard at the youth level of football and other sports with head impacts. "I think that's a very worrisome thing and should be a huge wakeup call," says Robert Cantu, neurosurgeon and co-author of the study released in Boston.
Diet's Role in Lowering Risk of Repeat Heart Attacks
Patients with heart disease frequently assume that medication is enough to forestall a repeat heart attack or stroke, but a large new study shows the preventive power of a healthy diet. The findings from a report, looked at the impact of diet in addition to the medicines routinely used to treat cardiovascular disease. Although it is widely accepted that healthy diets are powerful tools to prevent cardiovascular disease, less is known about the impact of diet on people who already have the disease. People with the healthiest diets—those with the highest intakes of fruit, vegetables, whole grains, nuts, and a higher intake of fish relative to meat poultry and eggs—were 35% less likely to die from a repeat heart attack or stroke during the length of the study, compared with those with the least healthy diets, according to the five-year study of 32,000 people in 40 countries.
Burning Question: Air Blowers or Paper Towels?
In June, the Mayo Clinic published a comprehensive study of every known hand-washing study done since 1970. The authors concluded that drying skin is essential to staving off bacteria, and that paper towels are superior to driers: They're more efficient, they don't spatter germs, they won't dry out hands and most people prefer them. Dr. Thompson's study was one of the dozen samples reviewed, and he concurs with the recent findings.
Clinical Decision Support May Boost HIV Patient Outcomes: Study
The use of an electronic clinical decision-support system may improve HIV patient outcomes, according to a study of such a system in December's Annals of Internal Medicine.
The study notes that despite the relatively narrow nature of the study, the system reviewed could be applied to other chronic conditions. "The alerting algorithms may be easily modified to monitor suboptimal follow-up, laboratory toxicities and disease markers specific to other illnesses, including diabetes mellitus, congestive heart failure and chronic viral hepatitis," the authors wrote.
Medicare Is Faulted on Shift to Electronic Records
The conversion to electronic medical records — a critical piece of the Obama administration’s plan for health care reform — is “vulnerable” to fraud and abuse because of the failure of Medicare officials to develop appropriate safeguards, according to a sharply critical report to be issued by federal investigators. The use of electronic medical records has been central to the aim of overhauling health care in America. Advocates contend that electronic records systems will improve patient care and lower costs through better coordination of medical services, and the Obama administration is spending billions of dollars to encourage doctors and hospitals to switch to electronic records to track patient care. But the report says Medicare, which is charged with managing the incentive program that encourages the adoption of electronic records, has failed to put in place adequate safeguards to ensure that information being provided by hospitals and doctors about their electronic records systems is accurate. To qualify for the incentive payments, doctors and hospitals must demonstrate that the systems lead to better patient care, meeting a so-called meaningful use standard by, for example, checking for harmful drug interactions.
Looking Ahead: Top Five Healthcare IT Trends for 2013
Trends Based on Positive Customer Results on Patient Engagement, Collaboration and Innovation
- A shift from stand-alone "unsponsored" apps to meaningful "sponsored" mHealth solutions
- Hospitals and other healthcare institutions including payers will begin to move more and more healthcare data into the cloud.
- Remote patient monitoring will move from pilots to large-scale adoption.
- Integrated mHealth applications will be created
- Upswing on telehealth to bridge the significant gap between physician resources and patient demand.
LIS, EHR Tying the Knot
The $19 billion federal program providing incentives to physicians and hospitals who can demonstrate “meaningful use” of electronic health records is entering a sweeping new phase in which laboratory information is a central part. Regulations for stage two of meaningful use were finalized in August. What does it mean for laboratories? The most important implication of the meaningful use program for laboratories and pathologists, says Walter H. Henricks, MD, medical director of the Center for Pathology Informatics at the Cleveland Clinic, is this: “As more physicians implement EHRs, there will be a dramatic increase in expectation for electronic interfaces between laboratory information systems and the EHRs.”
The meaningful use incentives have spawned hundreds of new electronic health record systems, says Pat Wolfram, vice president of marketing for Ignis Systems, Portland, Ore. Care providers have to order lab tests within the EHR to qualify for meaningful use stage two incentives. “And many of these newer EHRs haven’t built a comprehensive orders module yet that can create clean and complete requisitions for a lab. So expect to see requisitions coming to your lab in a variety of ways until those EHRs have matured that part of their products.”
Source: Source: http://www.cap.org/
Half of Docs Nationwide e-Prescribe Via EHRs
Just about one half of physicians nationwide are now performing electronic prescribing using an electronic health record on the Surescripts network, with all states producing double-digit increases. The percent of physicians e-prescribing using EHRs swelled from 7 percent in December 2008 to 48 percent in June 2012, according to a report released Nov. 27 from the Office of the National Coordinator for Health IT. Surescripts is a leading e-prescribing network, which is used by 95 percent of pharmacies for routing prescriptions, excluding closed systems such as Kaiser Permanente.
FDA Launches new Website for Medtech Export Documents
The FDA's Center for Devices & Radiological Health launched its Export Certification & Tracking System, a new website for submitting and processing export document requests electronically, an alternative to paper submissions.
The system could reduce the certificate processing time and allow the applicants to see real-time status updates online, but it is only currently available for certificates to foreign governments, which account for 95% of all export certificate requests, the FDA noted.
800 Companies, Groups Demand Repeal of Medical Device Tax
Starting January 1, medical-device makers must pay a new 2.3% excise tax on sales, regardless if they make a profit, to raise $30 billion over the next decade to pay for health reform. FOX Business has obtained a letter sent this month to the Senate from executives at more than 800 companies and medical groups demanding the tax be repealed as part of the fiscal cliff deal.
House Majority Leader Eric Cantor (R-Virginia) told FOX News that the 2.3% device tax should be part of the fiscal cliff deal, along with the health-reform law.
New ED Drama? Hospitals Demand Upfront Fee for Nonemergencies
More are charging patients up to $180 for problems deemed nonemergent. Some doctors say the policy could backfire and harm patients.
Physicians who take after-hours calls from patients often face a difficult decision: Which symptoms can wait for an office visit, and which ones require a trip to the emergency department? Now doctors find these decisions complicated by a troubling, rising trend: Will a trip to the ED mean an upfront charge for a patient if the problem is deemed nonemergent? At least half of hospitals are making efforts to collect patient co-pays, deductibles or other charges at the time of service in the emergency department, said Richard Gundling, vice president of health care financial practices at the Healthcare Financial Management Assn.
Dentists Now Get Paid More per Hour Than Doctors
Physicians' salaries have grown at an "anemic" pace in the past 15 years, while other health professionals' salaries have grown much faster, according to researchers from Harvard University and RAND Corporation. For a recent report in JAMA, researchers used survey data from 1987 to 2010 to measure differences in earnings among 6,258 physicians, 1,640 dentists, 1,745 pharmacists, 17,774 RNs, 761 physician assistants, and 2,378 health care and insurance executives. The report defined earnings as total yearly labor and business income (minus expenses). It excluded income from facility or medical technology ownership. They found that, from 1987 to 2010, the average physician's salary increased by 9.6%, while other health care professionals' average salaries increased by 44%. Specifically, from 1996 to 2010, average hourly wages for:
- Physicians increased from $65.40 to $67.30;
- Dentists increased from $64.30 to $69.60;
- Pharmacists increased from $37.80 to $50.60;
- RNs increased from $26.20 to $29.90;
- PAs increased from $21 to $31.20; and
- Health care and insurance executives increased from $39.60 to $42.50.
Report Finds ACOs Serving More Patients Than Expected
As many as 31 million Americans now receive healthcare through an accountable care organization (ACO) according to a recent report from industry consulting company Oliver Wyman. The report “The ACO Surprise” contends that while many believe that ACOs have had little impact on the market to date, the sheer numbers of patients getting healthcare via an ACO tells a different story. In its analysis, Oliver Wyman researchers determined that about 2.4 million Medicare beneficiaries were receiving care via the different Medicare ACO programs run by the Centers for Medicare & Medicaid Services; another 15 million non-Medicare patients received care at these Medicare ACOs; and 8 million to 14 million are part of ACOs run by large national and regional insurers for their non-Medicare populations. In total, the research indicates that nearly 45 percent of the population live in a primary care service area (PCSA) served by at least one ACO and 17 percent live in a PCSA that is served by two or more, a number that is likely to rapidly increase in the coming years, according to Richard Weil, co-author of the report.
UCLA Medical Center, 2 Other SoCal Hospitals Get "F" in Patient Safety Report
Three Southern California hospitals – including well-regarded UCLA Medical Center – received failing grades on a new nationwide patient safety report card. The "F" grade, issued by independent nonprofit The Leapfrog Group, was attacked by a University of California, Los Angeles chief medical official and defended by the nonprofit scoring group, which released its report recently.
The Hospital Safety Score examines largely preventable harm to patients that occurs at medical centers, using 26 measures of publicly available federal safety data to give hospitals a single score. "We're honed in on one thing, which is how likely is a hospital to harm a patient from an injury or an accident or an infection," said Leah Binder, chief executive officer of The Leapfrog Group, an organization founded by employers who purchase health care. "We're really looking exclusively at patient safety."
In addition to Ronald Reagan UCLA Medical Center, Western Medical Center in Anaheim and Palo Verde Hospital in Blythe, on the Arizona border, received "F" grades on the Hospital Safety Score. The ratings are available to the public at www.hospitalsafetyscore.org. The three Southern California institutions were among 25 nationwide that got an "F" on the survey. Dr. Tom Rosenthal, chief medical officer of UCLA Medical Center, defended his hospital and questioned Leapfrog's report.
The Price of Blood: China Faces HIV/AIDS Epidemic
With a long red AIDS ribbon pinned to his chest, Chinese Vice Premier Li Keqiang warned of the grave situation of HIV/AIDS in China, calling it "not only a medical issue but also a social challenge." On the week of World AIDS Day, the man expected to replace Wen Jiabao as premier next year, publicly acknowledged the nation's challenges with the epidemic.
The disease shows no sign of abating in the world's most populous country. AIDS related-deaths have increased by 8.6 percent to 17,740 deaths, compared with the previous year, according to the country's health figures. And 68,802 new HIV/AIDS cases were reported this year up to October, according to Chinese state media. But some HIV/AIDS advocates say the number of cases is underestimated, in part because many people who have HIV/AIDS may never have been tested to know their status.
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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