A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
May 2, 2013
View Previous Issues - Healthcare News Archive
FDA Issues Emergency Use Authorization for PCR-based A(H7N9) Influenza Virus Assay
The US Food and Drug Administration issued an emergency use authorization, or EUA, for a Centers for Disease Control and Prevention assay for the detection of influenza A virus subtype H7N9. FDA issued the EUA for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay for the "presumptive detection" of influenza A(H7N9) in conjunction with the FDA-cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR (rRT-PCR) assays. The assay is to be used for patients who show signs and symptoms of respiratory infection, FDA said. The assay will be distributed by CDC to public health and other qualified laboratories only and is to run on the FDA-cleared Applied Biosystems 7500 Fast Dx Real-Time PCR platform.
GOP Bill Would Force Federal Workers Onto Health-Care Exchanges
A new Republican House proposal would push federal workers off their employer-sponsored health plan and onto the insurance exchanges being established under the Affordable Care Act. Rep. Dave Camp (R-Mich.), chairman of the House Ways and Means Committee, introduced the bill after talk on the Hill that Democrats were trying to exempt members of Congress and their staffs from a provision in current law that requires them to enroll in the exchanges in 2014. Camp’s measure would extend that policy to all federal workers except active-duty military members and postal workers. “If the Obamacare exchanges are good enough for the hardworking Americans and small businesses the law claims to help, then they should be good enough for the president, vice president, Congress and federal employees,” said Camp spokeswoman Sarah Swinehart. Most employees who would be affected by the proposal are enrolled in the Federal Employees Health Benefits Program. Labor groups that represent federal workers oppose the Camp proposal.
Federal Panel Says Everyone 15 to 65 Should Have HIV Test
Citing recent evidence that HIV infections are best managed when treated early, an influential panel of medical experts has finalized its recommendation that all people ages 15 to 65 be screened for the virus that causes AIDS. The recommendation from the U.S. Preventive Services Task Force seeks to address one of the key challenges in the fight against HIV/AIDS: The window during which patients respond best to treatment is also the time when symptoms of the disease are least noticeable. The guideline is being released after a number of well-publicized cases in which early treatment with a combination of powerful antiretroviral drugs has greatly improved patient survival rates. In one of those instances, doctors reported in March that an infant in Mississippi who began aggressive drug treatment immediately after birth had been "functionally cured" of HIV.
Improving Early Detection of HIV
Study Examines Alternative CDC Algorithm with New Assay
Clinicians and laboratorians have praised CDC’s proposed alternative HIV testing algorithm, which calls for initial screening with a fourth-generation immunoassay. However, many labs have not yet adopted fourth-generation tests. In this issue of Strategies, researchers explain how a recent study demonstrates the benefit of the new algorithm as the lab community navigates a transition to the latest assays.
The current Centers for Disease Control and Prevention (CDC)-recommended testing algorithm, in place since 1989, calls for screening with an enzyme immunoassay (EIA), followed by validation of repeatedly reactive specimens using Western blot. However, a major weakness in this strategy is that Western blot does not detect infections in the window period of about 40 days when measurable levels of antibodies are not yet present.
CDC proposed a new algorithm to improve detection of acute infections in 2010. This alternative algorithm calls for screening with a fourth-generation immunoassay that detects p24 antigen, which increases between infection and seroconversion. Positives are followed by an HIV-1/HIV-2 differentiation immunoassay, while a nucleic acid test (NAT) is used to resolve the status of an initial positive immunoassay result followed by a negative differentiation test.
Medicare Panel to Mull Genetic Cancer Tests
Genetic tests to help oncologists determine the previously unknown origin of metastatic tumors work moderately well, members of a Medicare coverage advisory committee were told. However, analytic and clinical evidence is limited on another category of genetic tests: those that search for DNA from high-risk, cancer-causing human papillomavirus (HPV) to detect cervical cancer earlier. The Medicare Evidence Development and Coverage Advisory Committee will meet in Baltimore to consider evidence about both types of tests as the Centers for Medicare and Medicaid Services (CMS) ponders whether to cover their use. Committee members will be asked their degree of confidence in the tests' clinical validity as well as the tests' ability to improve outcomes.
New Guidance on Genetic and Genomic Testing
In the fast-moving field of molecular diagnostics, the American College of Medical Genetics and Genomics (ACMG) recently released guidance on two emerging issues of importance: non-invasive prenatal screening for fetal aneuploidy (NIPS) and reporting incidental findings from whole exome or genome sequencing.
In a policy statement on NIPS, ACMG noted that analyzing cell-free fetal DNA from maternal blood for fetal aneuploidy is likely the first of major steps toward fetal genome or exome sequencing. Promising studies of this method have shown high sensitivity and specificity with a low false-positive rate. However, ACMG cited 10 limitations of NIPS, including: identifying only three aneuploidies—leaving undetected about half those picked up by amniocentesis; not detecting chromosomal abnormalities such as deletions and duplications; and having longer turnaround times than tests of maternal serum analytes. For these reasons, ACMG recommends that women undergo invasive testing to confirm positive NIPS results.
At AACR, Early Providers of NGS-based Cancer Panels Debate 'Actionable' Mutations, Regulatory Issues
At the annual meeting of the American Association for Cancer Research, a number of similarities emerged among labs offering cancer gene panels on next-gen sequencing platforms. For example, several groups that offer such services reported that lung cancer is the most common tumor type they see, followed by breast cancer and colorectal cancer. Likewise, these labs all see the same top three mutated genes: TP53, PI3K, and KRAS. But these groups diverge a bit when it comes to deciding what clinical action to take based on the information gleaned from such tests. Academic labs increasingly view NGS-based cancer panels as a cost-effective — and tissue-saving — alternative to running a series of multiple single-gene companion tests, but they are bumping up against challenges in clinical decision-making because the results invariably lead to regulatory questions about the off-label use of targeted drugs. While there have been a number of published reports showing that sequencing results led to a dramatic response to an off-label use of a targeted therapy, the success rate of this approach is still unclear.
Laboratory Testing for Ricin
Testing for ricin in environmental samples
When a reference laboratory receives an environmental sample suspected of containing ricin, the laboratory performs specific tests to detect the presence of the agent. Tests performed on ricin-suspicious samples include the following:
- Time-resolved fluorescence immunoassay: In this test, the laboratory technicians use an antibody that binds to ricin to enable them to detect it in environmental samples.
- Polymerase chain reaction (PCR): PCR is a test used to locate and make copies of parts of the DNA contained in the castor bean plant. The search can specifically look for the DNA of the gene that produces the ricin protein.
- HPLC-ESI-MS: CDC has developed a method for measuring ricinine, a marker of ricin exposure, in urine. Ricinine is present along with ricin in castor beans. CDC has transferred the ricinine testing method to selected LRN laboratories. These laboratories participate in proficiency testing three times per year for the ricinine testing method.
Promising New Noninvasive Test for Prostate Cancer Uses Laser Optics Plus Ultrasound Imaging
Multispectral photoacoustic imaging, which combines laser optics and ultrasound imaging technologies, can reliably distinguish between benign and malignant prostate tissue, a new study indicates. Researchers at the University of Rochester looked at 42 prostatectomy specimens using the new imaging technique. Multispectral photoacoustic imaging, still in its infancy, predicted 25 out of 26 benign tissues correctly and 13 out of 16 malignant tissues correctly, said Dr. Vikram Dogra, lead author of the study. Dr. Dogra said “We expect this technique to be clinically available in about five years," he added.
Device Detects Blood Fungal Infections Rapidly
Portable device detects Candida bloodstream infections accurately
A small, portable device can detect Candida bloodstream infection, an often fatal fungal bloodstream infection, rapidly and accurately, according to a study published in the April 24 issue of Science Translational Medicine. Noting that bloodstream infections of Candida spp have a 40 percent mortality rate due to long diagnostic times, Lori A. Neely, Ph.D., from T2 Biosystems in Lexington, Mass., and colleagues tested a diagnostic based on T2 magnetic resonance (T2MR). They used blood-compatible polymerase chain reaction to amplify Candida DNA from human whole blood, which then binds to nanoparticles coated with a complementary DNA probe and yields nanoparticle clusters, changing the sample's T2MR signal. The researchers found that the T2MR detection device could rapidly, accurately, and reproducibly detect as little as one colony-forming unit of five Candida species in less than three hours.
Cell Sorting Device Improves Detection of Circulating Tumor Cells
An automated cell sorting device developed in the USA may allow circulating tumor cells (CTCs) to be detected with greater accuracy than by current methods, say researchers. The device, called the CTC-iChip, "is capable of sorting rare CTCs from whole blood at 107 cells per second," say Mehmet Toner (Harvard Medical School, Boston, Massachusetts, USA) and team. They add: "Most importantly, the iChip is capable of isolating CTCs using strategies that are either dependent or independent of tumor membrane epitopes, and thus applicable to virtually all cancers." When used on whole blood samples, the iChip's magnetic labeling and microfluidic sorting functions allowed CTCs to be isolated from a variety of epithelial and nonepithelial cancer types, such as breast, lung, and prostate cancer. And this CTC isolation was performed with greater sensitivity than existing cell sorting devices, say Toner and team.
First Lab-on-Chip for Detecting Multiple Tropical Diseases
Veredus Laboratories has developed the first biochip in the molecular diagnostics market that can identify 13 different major tropical diseases from a single blood sample, testing for killers such as dengue fever, malaria, chikungunya, and hand, foot and mouth disease, in the field. The team from SIgN has successfully validated the kit on patient samples in the external fields of Northern Thailand, at the Thai-Myanmar border.
Nose Tissue is Key to Better Schizophrenia Diagnosis
Noam Shomron and Prof. Ruth Navon of Tel Aviv Univ.'s Sackler Faculty of Medicine, together with PhD student Eyal Mor from Shomron's lab and Prof. Akira Sawa of Johns Hopkins Hospital, have discovered a method for physical diagnosis — by collecting tissue from the nose through a simple biopsy. Surprisingly, collecting and sequencing neurons from the nose may lead to "more sure-fire" diagnostic capabilities than ever before, Shomron says. This finding, which was reported in the journal Neurobiology of Disease, could not only lead to a more accurate diagnosis, it may also permit the crucial, early detection of the disease, giving rise to vastly improved treatment overall.
Meet the Clinical Pathology Laboratory on the Palm of a Hand: Japanese Researchers Announce a Point-of-Care Testing Device That Detects MicroRNA in 20 Minutes
Second-generation device is self-powered, does not require a trained operator, and amplifies the fluorescence signal by 1,000-fold, enabling early detection of cancer Pathologists will be interested to learn that Japanese researchers have developed a second-generation lab-on-a-chip that detects microRNA (miRNA) from a tiny sample volume in only 20 minutes! Their goal is to create a point-of-care device for early detection of cancer. Scientists achieved this groundbreaking work at Japan’s RIKEN Advanced Science Institute.
Exact Sciences Colorectal Cancer Screening Test Meets Goal
Exact Sciences Corp said its non-invasive molecular screening test for colorectal cancer met a late-stage trial goal of detecting the disease in more patients than other commonly used screening tests. The Cologuard test identifies abnormal DNA in cells shed in a patient's stool. Preliminary, top-line data from the DeeP-C trial show that the test demonstrated 92% sensitivity for the detection of colorectal cancer and 42% sensitivity for the detection of pre-cancerous polyps, including 66% sensitivity for polyps equal to or greater than 2 centimeters. The test achieved a specificity of 87% during the trial.
A device that reveals counterfeit drugs in the hands of Food & Drug Administration agents is set to become the newest weapon in the worldwide effort to eradicate malaria, and may soon be used to detect useless look-alikes of drugs that combat cancer, heart disease and viral infections.
FDA Commissioner Margaret Hamburg unveiled an initiative aimed at putting simple handheld versions of the FDA device into the hands of public health field workers in Ghana to help root out counterfeit malaria drugs. In sub-Saharan Africa, 20% of the drugs used to fight malaria are outright counterfeits, and 35% are "substandard"--meaning they are not potent enough to treat a patient's malaria.
Newfound Hormone Holds Hope for Diabetes Treatment
The new research suggests that giving diabetics a hormone might help them avoid insulin shots.
A newly discovered mouse hormone may open the door to better treatment for diabetes, researchers suggested. The hormone, called betatrophin, triggers the growth of pancreatic "beta" cells lost or ineffective in diabetes. Insulin is produced by beta cells in the pancreas. In the journal Cell, a team led by Harvard's Peng Yi reports that betatrophin can produce a roughly seventeenfold increase in these cells, and its increase may partly explain the rapid growth of these cells seen during pregnancy to feed developing fetuses in mammals, including people. "This is really an amazing discovery. Hormones with this kind of effect aren't discovered very often, and this opens a whole new pathway to treating diabetes," says diabetes expert Jake Kushner of the McNair Medical Institute at Baylor College of Medicine in Houston, who was not part of the study team.
Beta-Cell Dysfunction May Drive Diabetes in Asian Indians
Impaired pancreatic beta-cell function seems to play a larger role than insulin resistance in the very early stages of type 2 diabetes in Asian Indians, according to a new study, published online April 17 in Diabetes Care. The study "counters what we have traditionally or historically thought, [in that] insulin resistance has been considered the driving factor in [type 2] diabetes," first author Lisa R. Staimez, MPH, from Emory University, in Atlanta, Georgia, told Medscape Medical News.
Study Suggests Bats May Be Common Reservoir for Hepatitis C-related Viruses
Bats can carry a wide range of viral representatives resembling hepatitis C virus, a new study suggests. In the early, online version of the Proceedings of the National Academy of Sciences, an international group led by investigators at Columbia University used RNA sequencing to look at the sorts of viruses found in blood samples from hundreds of bats collected in Africa and Central America. "The prevalence, unprecedented viral biodiversity, phylogenetic divergence, and worldwide distribution of the bat-derived viruses suggest that bats are a major and ancient natural reservoir for both hepaciviruses and pegiviruses," senior author Ian Lipkin, with the center for infection and immunity at Columbia University's Mailman School of Public Health, and colleagues wrote, "and provide insights into the evolutionary history of hepatitis C virus and the human GB viruses."
Variations on a Gene, and Tools to Find Them
CANCERS were once named strictly for the tissue where they originated in the breast, prostate or other part of the body. Now, in the age of genetically informed medicine, cancers may also come with a more specific lexicon: the names of mutated genes deep within tumors that cause cells to become cancerous. Most of these gene flaws — there are scores of them, and they have names like BRAF V600E — are relative newcomers to medical terminology, as are most of the anticancer drugs, still in early testing, that are aimed at them. Development of the new drugs has been spurred by the falling cost of decoding DNA and the prospects of premium prices for drugs that specifically attack the molecular drivers of cancer. To guide doctors and their patients, many tools are on the market, including one created by Dr. Pao and colleagues: the Web site My Cancer Genome.
Artificial blood vessels may one day reduce some complications of dialysis treatment in people with kidney failure, according to the results of early research in animals. These so-called "off-the-shelf" blood vessels were implanted in the primates for six months and withstood frequent needle punctures, were not rejected by the immune system, remained free of blood clots, and were safely stored in a refrigerator for up to one year, the researchers said.
Toddler Is Youngest to Ever Get Lab-Made Windpipe
A 2-year-old girl born without a windpipe now has a new one grown from her own stem cells, the youngest patient in the world to benefit from the experimental treatment. Hannah Warren has been unable to breathe, eat, drink or swallow on her own since she was born in South Korea in 2010. Until the operation at a central Illinois hospital, she had spent her entire life in a hospital in Seoul. Doctors there told her parents there was no hope and they expected her to die.
To [vitamin] D or not to D? That is the question
Copenhagen, Denmark-Two leading experts in the field of vitamin D agreed to disagree at the 2013 European Congress on Endocrinology during a lighthearted debate on the subject of whether or not everyone needs more vitamin D. But their arguments were backed up by some serious science, and they both concurred that there are certain groups of people in whom it is necessary to ensure that vitamin-D levels are sufficient, such as pregnant women and those at risk for or with osteoporosis. And they also agreed on one way people can obtain more vitamin D: by going out in the sun for 30 minutes per day. Where they differed, however, was that the vitamin-D proponent, Dr Chantal Mathieu (Catholic University, Leuven, Belgium) said the list of people who need sufficient vitamin D "is so long that it really just makes more sense to give everyone small doses."
PhRMA Report Lists 241 Drugs Under Development for Blood Cancer
More than 200 drugs for blood cancers are under development, according to a new report by a drug industry trade group. The Pharmaceutical Research and Manufacturers of America said 241 medicines were in clinical development or under review by the Food and Drug Administration, including 98 for lymphoma, 97 for leukemia, 52 for multiple myeloma and 24 for malignancies of the bone marrow, blood and lymph nodes.
Merck’s HPV Vaccine May Protect Girls With Fewer Doses
Two doses of Merck & Co. (MRK)’s human papillomavirus vaccine may be just as effective in younger girls as the recommended three doses given to older teens and women to help protect them against the virus that causes cervical cancer, a Canadian study found. Girls ages 9 to 13 years who received two doses of Gardasil had antibody levels that were not worse than females ages 16 to 26 years who received three doses, according to research in the Journal of the American Medical Association.
Outpatient is in: 69 percent of survey respondents projected an increase in outpatient volume for 2013, while only 35 percent predicted an increase in inpatient volume. The Premier Healthcare Alliance survey gathered responses from 530 hospital C-suite, materials and practice area managers on their 2013 economic outlook, including capital investment plans and ACO intentions.
Follow the money
Forty-three percent of respondents plan to make health IT their biggest capital investment in 2013, up from 21 percent two years ago.
FDA Wants You (to Get Involved)
You may know that the Food and Drug Administration (FDA) is responsible for protecting your health by ensuring that the food you eat is safe, and that the drugs and medical products you and your family use are safe and effective.
But did you also know that FDA needs your help?
"It's true," says Richard Klein, director of FDA's Patient Liaison Program within the Office of Health and Constituent Affairs5. "We invite consumers to get involved in the process of helping FDA make the decisions that affect their lives."
And thanks to FDA's Patient Network initiative, it's easy.
New Health Insurance Form Now Down to Three Pages
After months of jokes about the new form for the health insurance marketplaces being longer than the 2010 health care law, the government has released a new, "short" three-page form, down from 21 pages. A second form for families has been reduced by two-thirds, according to the Department of Health and Human Services.
"Consumers will have a simple, easy-to-understand way to apply for health coverage later this year," said Centers for Medicare acting administrator Marilyn Tavenner. "The application for individuals is now three pages, making it easier to use and significantly shorter than industry standards."
State to Skip Federal Funds Over Sex Questions
For at least a decade, Georgia has steadfastly refused to include questions about sexual behavior in a CDC-sponsored survey of high school students. Now that decision apparently will cost the state a shot at federal money for HIV/STD prevention. In an April 4 letter from a Department of Education official to the CDC, the state said it would not apply for a round of federal funding for HIV/STD education because “it will not be able to comply with the new requirements.’’ Those new rules from the CDC require a state to include sex questions in the Youth Risk Behavior Survey in order to qualify for the extra funds. The CDC said the survey data are needed to measure outcomes that contribute to the reduction of HIV infection and other STDs among adolescents. The 2013 national YRBS is in the field right now, a CDC spokeswoman said. Data collection will be complete at the end of this school year, the official said.
Last Chance for Quality Reporting Before Medicare Penalty Kicks in
A recent Centers for Medicare & Medicaid Services analysis of PQRS and electronic prescribing initiatives in Medicare showed a higher number of physicians engaged in quality reporting activity in 2011 than in the previous year. More than 320,000 eligible health care professionals submitted PQRS data, compared with about 100,000 during the inaugural 2007 reporting period. At least 200,000 more would need to participate in PQRS in 2013 to achieve a CMS goal of at least half of all health professionals avoiding the first penalty, which will apply to 2015 payment rates. To prevent the penalty, a physician needs to send a valid quality measure code at least once in 2013. The 2011 reporting experience analysis showed that 29% of eligible professionals, up from 15% in 2007, had achieved that minimum threshold for participation.
Missed, Wrong Diagnoses Most Dangerous Errors, Study Says
They rarely get the attention paid to never events, such as wrong-site surgery or death from a medication error, but errors involving missed, delayed or incorrect diagnoses are the most common, costly and dangerous mistakes made in the U.S. healthcare system, argue the authors of a study in the journal BMJ Quality & Safety. Researchers analyzed 25 years of malpractice data from the National Practitioner Data Bank, looking specifically at more than 350,000 claims that led to payouts. Such errors lead to an estimated 40,000 to 80,000 hospital deaths a year in the U.S., according to research cited in the study. More than 25% of the analyzed allegations, or 100,249 claims, were diagnosis-related, with outcomes ranging from death to minor permanent injury, the authors found.
Hospital Safety: Your Responsibility or Theirs?
Airline passengers don’t review the preflight checklist with the pilot, and restaurant customers aren’t expected to check the kitchen and the staff for cleanliness. But many health care experts say it’s wise for hospital patients and their families to ask doctors and nurses to wash their hands, remove unnecessary catheters and explain how they will prevent an infection from developing after surgery. The advice is an acknowledgement of reality: a hospital can be a dangerous place to spend the night. Comprehensive infection control is still a goal rather than a fact at most hospitals. On hand-washing alone, for example, healthcare workers comply only about half the time, studies have shown. And one in 20 patients will acquire an infection while in the hospital.
Even so, speaking up for yourself in that setting is not an easy thing to do.
“No one wants to be confrontational with the person you hope will save your life,” said Dr. Michael Bell, acting director of the division of healthcare quality promotion at the U.S. Centers for Disease Control and Prevention in Atlanta. Nonetheless, Bell and other experts advise patients and their families to be vigilant.
Identification of Physician Impairment
When a critical event occurs in most high-risk industries (such as airlines, nuclear power, or railways), a detailed investigation examines a variety of system and individual factors (such as fatigue and substance abuse) that caused or contributed to the event. Directly involved individuals are commonly tested for alcohol and other drugs. Airplane pilots and truck drivers are tested following crashes and near misses. Some law enforcement officers are tested following fatal shooting incidents. Mandatory alcohol-drug testing for clinicians involved with unexpected deaths or sentinel events is not conducted in medicine. Yet alcohol, narcotic, and sedative addiction is as common among physicians as the general population, and physicians are as susceptible to the effects of prescription and nonprescription drugs and alcohol as any other person.
CPOE Use Can Reduce Unneeded CT Scans
Using a computerized physician-order entry system with a redundancy alert can reduce unnecessary CT scans, saving money and avoiding extra dose, according to a study published this month in JAMA. In the study, conducted by researchers at Harvard Medical School and the Center for Evidence-Based Imaging in Brookline, Mass., physicians received an alert when they ordered CT scans for patients who had received one in the same part of the body within the past 90 days. Though the percentage of canceled studies is low, study authors believe even small net changes could lead to cost savings due to the volume and cost of CT scans
Patient's Photo on X-Ray Images Leads to Dramatic Drop in Wrong Patient Errors
Adding a photo of a face to x-ray images can reduce "wrong-patient" errors five-fold, a new study finds. "X-rays can look alike, and if one patient's images are confused with another before the radiologist sees them, it can be difficult for the radiologist to determine there is a mismatch," said Dr. Srini Tridandapani, of Emory University and an author of the study. The study required additional personnel to take the pictures of the patients immediately after the patients' x-ray examination. However, Dr. Tridandapani and his colleagues have developed a prototype system where the camera can be attached to a portable x-ray machine; the picture is taken without additional personnel. The study, jointly conducted at Emory University and Georgia Institute of Technology, was presented at the ARRS annual meeting in Washington, DC.
The new WiFi standards 802.11ac and 802.11ad could drive a new wave of connectivity in hospitals, according to Jay Botelho, director of product management at WildPackets, a company that develops networking hardware and software. Due for ratification by the Institute of Electrical and Electronics Engineers (IEEE) in December, 802.11ac will become the new WiFi standard, picking up where 802.11n left off, according to Botelho. It will incorporate channel bonding and multiple input-multiple output (MIMO) technology, allowing for sending data over multiple antennas at the same time,
New Website Will Disclose Health Industry Payments to Doctors
For the first time, the government will make information about financial relationships between doctors, teaching hospitals and drug manufacturers publicly available. To comply with a provision in the Affordable Care Act, drug and device manufacturers, along with group purchasing organizations, will have to disclose all of their payments and other compensation to physicians and teaching hospitals. Those who don’t comply could be fined. The information will be gathered beginning in August and disclosed by Sept. 30, 2014 on a new website of the Centers for Medicare & Medicaid Services
Guidance Issued for US Internet Research
An advisory committee to the US Department of Health and Human Services (DHHS), which governs human-subjects research, has endorsed a 20-point set of recommendations that could help. But some scientists worry that the recommendations might place more areas of Internet research under the purview of IRBs, which have been attacked by their critics as capricious, overly cautious groups that add time, complexity and costs to studies. Although the DHHS secretary has not officially endorsed the recommendations, administrators say it is already being used. “People are going to use this whether it gets blessed officially beyond this committee or not, because it is so urgently needed,” says Susan Rose, the University of Southern California’s executive director for the protection of research subjects.
NIST Reworks Cyber Guidelines for the Hacking Era
The National Institute of Standards and Technology has rewritten federal cybersecurity standards for the first time in nearly a decade to address evolving smartphone vulnerabilities and foreign manipulation of the supply chain, among other new threats. The 457-page government computer security bible, officially called "SP (Special Publication) 800-53," was last revised in 2005. That was long before the rise of advanced persistent threats…. Agencies are not required to follow all the specifications, but rather choose among the protections that suit their operational environments.
Health IT Salaries Lag Behind Overall IT Industry
While demand for IT talent in healthcare remains high, salaries appear flat according to InformationWeek's 2013 U.S. IT Salary Survey. The demand, however, indicates continuing upward pressure on salaries, the report says. It finds no rise from a year ago in median annual base pay at $83,000, compared with $87,000 for IT pros across all industries. Healthcare IT managers received a slight boost in average base pay to $112,000, up from $109,000 in 2012, more than the industry average of $110,000.
As hospitals and eligible providers work to meet the government’s 2015 deadline for implementing electronic health record systems to comply with the HITECH Act of 2009, are laboratory-provider links (LPL) software companies being left out in the cold?
No, they say. In fact, they’re adding new products and services to meet new demands.
Brian Keefe, director of laboratory software solutions marketing for Psyche Systems, says the complexity of most lab testing will leave EHRs struggling to support the type of information lab reporting requires. “EMR companies are not set up or designed to handle the influx of integration requirements to begin to meet the demand of laboratory EMRs,” he says. In fact, Keefe adds, “Some LPL companies are developing advanced analytical functionality for customized tests that standard EMRs could never hope to support.” It’s an expanding area of the laboratory market where LPLs will be needed.
Certification for Electronic Health Record Product Revoked
Two electronic health records, previously certified as products to be used as part of the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, have had their certifications revoked. Farzad Mostashari, M.D., the national coordinator for health information technology, announced that the products do not meet standards and providers cannot use these products to meet the requirements of the Medicare and Medicaid EHR Incentive programs. Information about ONC’s certification process for EHR technologies is available at http://www.healthit.gov/providers-professionals/certification-process-ehr-technologies.
Government Driving Health IT in Asia-Pac
Taking a cue from U.S. stimulus initiatives such as HITECH, Asia Pacific countries are seeing a big uptick in electronic health record adoption thanks to government investment, according to a new report from Frost & Sullivan. A combination of regulations and incentives is spurring adoption of EHR systems in Asia-Pacific countries as the region's healthcare industry moves towards digitization, according to Frost & Sullivan. Governments, non-profit entities and the private sector are aggressively investing in health IT projects at both regional and local levels in an effort to achieve seamless information exchange and recognize cost savings and improved clinical outcomes.
Nigeria: '50 Percent of Nigerian Lab Results Unreliable'
Association of Pathologists of Nigeria (APN) said substandard and fake laboratories around the country are responsible for half of all lab results considered unreliable, leading to wrong diagnosis by physicians and even deaths. President of APN, Dr Kenneth Iregbu, said interaction with doctors led to the estimates that "50 percent of results sent to the clinicians are of no value to them in the management of patients."
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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