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DLPSS|HEALTHCARE NEWS|June 5, 2014 ► A Weekly Compilation of Clinical Laboratory and Related Information From The Division Of Laboratory Programs, Standards And Services

DLPSS|HEALTHCARE NEWS|June 5, 2014





Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information 
from The Division Of Laboratory Programs, Standards And Services

 

June 05, 2014


News Highlights 

 

View Previous Issues - Healthcare News Archive

 

The Essential Role of Laboratory Professionals: Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems

The CDC has announced the availability of a report titled, The Essential Role of Laboratory Professionals: Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems. The announcement appeared in Morbidity and Mortality Weekly Report’s May 16, 2014 edition. The report was written by CDC’s LabHIT Team following a recommendation from theClinical Laboratory Improvement Advisory Committee (CLIAC) to identify issues and opportunities associated with the use of laboratory data in electronic health records.

The LabHIT Team is in the Division of Laboratory Programs, Standards and Services in the Center for Surveillance, Epidemiology and Laboratory Services (CSELS) at the CDC. The Division works in partnership with CMS and FDA, providing scientific and technical expertise in support of the Clinical Laboratory Improvement Amendments (CLIA) program.
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Cleveland Clinic Initiative Prevents Unnecessary Tests and Improves Patient Care

A program at Cleveland Clinic reduced the number of unnecessary lab tests by blocking physicians from ordering the same test for hospitalized patients more than once a day. According to a recent study published in the American Journal of Clinical Pathology, the initiative prevented nearly 12,000 unnecessary tests over a two-year period. The program aimed to improve patient satisfaction by preventing unnecessary needle sticks, as well as to reduce anemia caused by excess blood draws. As an added benefit, the reduction in tests resulted in a cost saving of more than $183,000.
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Assessing Accuracy on the Front Lines: A Pragmatic Approach for Single-Donor Proficiency Testing

Proficiency testing (PT), also known as external quality assessment (EQA), has earned a well-deserved position as one of the most important elements of a laboratory's quality management program. By assessing its performance on blinded samples, a laboratory can determine to what extent its results agree with those of its peers or, ideally, with the reference method.  Unfortunately, as has been emphasized recently, the most frequently used PT materials are noncommutable, meaning that they do not behave exactly like real patient samples. Conclusions drawn from such materials are, of necessity, limited to understanding how well any given peer group performs rather than knowing whether the results on patient samples are, in fact, accurate. In the case of a method lacking a true peer group (including, for example, the overwhelming majority of mass spectrometry methods and other laboratory developed tests), even this limited type of comparison may not be possible. Additionally, when there are differences between peer groups comprising laboratories that use homogeneous systems (single manufacturer's instruments, calibrators, and reagents), the differences are often ascribed to lack of commutability (matrix effects) of the materials, although the differences may in fact be real and reflected in patient samples as well.
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The Continuing Search for Alzheimer’s Biomarkers

Despite extensive research on Alzheimer’s disease (AD), this devastating neurodegenerative condition is an enormous continuing social and public health problem. More than 5 million Americans live with AD, and the total national cost of caring for people with AD and other dementias is projected to reach $214 billion during 2014, according to the Alzheimer’s Association. The disease also takes a huge toll on the nation’s 15.5 million caregivers—usually family members—who, as the disease progresses, provide nearly constant unpaid care. Without medical advances leading to viable treatments, the already substantial burden of AD is expected to continue to weigh down society and the healthcare system. Imagine three times more AD patients, a figure the Alzheimer’s Association predicts could materialize by 2050 absent significant diagnostic and treatment strides.  The Food and Drug Administration has approved five drugs that temporarily offset memory and other cognitive loss and three agents for use with positron emission tomography (PET) of the brain. PET estimates amyloidβ (Aβ) plaque density in cognitively impaired patients who are being evaluated for AD and other causes of cognitive decline. But a more cost-effective test to spot early AD remains elusive.
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FDA Okays Noninvasive Kidney Test

The FDA has approved a new noninvasive test to help determine whether patients have primary membranous glomerulonephritis (pMGN). The Euroimmun Anti-PLA2R IFA blood test detects the antibody specific to pMGN, which helps determine whether patients need aggressive treatment. In the past, diagnosis could only be done via kidney biopsy -- although the FDA notes that the test shouldn't be used alone to diagnose pMGN and that symptoms and laboratory work should also be used to confirm the diagnosis. Additionally, "a negative result from the test does not rule out a diagnosis of pMGN," the agency noted, adding that the test shouldn't yet be used to monitor the stage of disease or response to treatment. 
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Study Compares Ability of Expression Arrays, RNA-seq to Profile Cell-free Fetal RNA Transcriptome

A team of researchers from Tufts Medical Center recently assessed the ability of microarrays and next-generation sequencing to profile gene expression in cell-free fetal RNA obtained from amniotic fluid supernatant. They found that expression microarrays provided a broader view of gene expression, particularly in low-concentration or degraded samples, an area where RNA-seq suffered from "technical challenges." At the same time, they noted that RNA-seq data provided a better focus on alternative splicing and specific biological pathways relevant to the developing fetus. The results are detailed in a paper published last week in the journal Prenatal Diagnosis.

Compact and Extremely Small-Scale Incubator Microscope to Examine Cells in Time Lapse

Biologists and doctors rely heavily on incubators and microscopes. Now the Fraunhofer Institute for Biomedical Engineering IBMT has come up with a novel solution that combines the functions of both these tools in a compact and extremely small-scale system. It is ideally suited for time-lapse examination over a number of weeks and for automatic observation of cell cultures. The incubator microscope is no bigger than a soda can and costs 30 times less than buying an incubator and a microscope separately. Prototype versions are already in use in a variety of research projects. “The system is stable and can be used for time-lapse observation spanning several weeks,” says Dr. Thomas Velten, head of the Biomedical Microsystems department.

A Breathalyzer That Can Diagnose Cancer

If a fingerprint can tell someone who you are, a "breathprint" could reveal how you're doing. That's according to Raed Dweik, the doctor who runs the pulmonary vascular program at the Cleveland Clinic's Respiratory Institute. For the past two decades, Dweik has been studying the molecular patterns in breath that can reveal what's happening inside the body. Though Dweik believes breath testing is the "next frontier" in medical diagnoses, technological advancements lag behind clinical ones. The "Holy Grail of breath testing" would be a Breathalyzer-style device that a person could carry in her pocketbook and use any time, Dweik says. Manufacturers are already working on it. Vantage Health is using NASA technology to develop cancer-screening breath-test devices that could be attached to a smartphone and would relay data to an app. 
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Study Affirms Value of Epigenetic Test for Markers of Prostate Cancer

A multicenter team of researchers report that a commercial test designed to rule out the presence of genetic biomarkers of prostate cancer may be accurate enough to exclude the need for repeat prostate biopsies in many — if not most — men. “Often, one biopsy is not enough to definitively rule out prostate cancer,” says study researcher Jonathan Epstein, M.D., director of the Division of Surgical Pathology and a professor of pathology, urology and oncology at the Johns Hopkins University School of Medicine. “Our research finds that by looking for the presence or absence of cancer in a different way, we may be able to offer many men peace of mind without putting them through the pain, bleeding and risk of infection that can come with a repeat biopsy.” The new research, called the Detection of Cancer Using Methylated Events in Negative Tissue (DOCUMENT) study, suggests that an initial biopsy complemented with an epigenetic diagnostic test accurately rules out the existence of cancer up to 88 percent of the time. The test, developed by MDxHealth, which paid for the study, was described online in April in The Journal of Urology. The epigenetic biomarkers the test detects reflect a process called DNA hypermethylation, in which a methyl group is chemically attached to DNA — in this case, to genes called GSTP1, APC and RASSF1. These genes are known to play prominent tumor suppressive roles in key cancer-related pathways. When these genes are hypermethylated, they are commonly silenced, which can lead to a loss of this tumor-suppressing function and the emergence of cancer.
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Hounds Astound: Prostate Cancer Found 100% (Around)

With an accuracy rate of nearly 100%, 2 specially trained dogs were able to detect prostate cancer with their olfactory system — by sniffing urine samples, according to a new study that is the largest of its kind. Italian researchers tested each dog's ability to sniff out prostate cancer in urine samples from 362 men with prostate cancer and 540 men with either non-neoplastic prostate disease or nonprostatic tumors. The dogs, German Shepherds named Liu and Zoey, had their day, time and again. Liu had an accuracy rate of 99.0%, with a sensitivity of 100.0% and specificity of 97.8%. Zoey had an accuracy rate of 97.0%, with a sensitivity of 98.6% and specificity of 95.9%. "This is a real clinical opportunity," said lead researcher Gianluigi Taverna, MD, chief of the prostatic disease unit at Humanitas Research Hospital in Milan, about the results. The opportunity includes the possibility that specially trained dogs could provide a noninvasive method of cancer detection. He spoke during a press conference at the American Urological Association (AUA) 2014 Annual Scientific Meeting.
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Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Serological Reagents

The Food and Drug Administration (FDA) is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the dengue serological reagents classification will include the identification of the special controls that will apply to this device. The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.

Microbiology Devices; Reclassification of Nucleic Acid-Based Systems forMycobacterium tuberculosis Complex in Respiratory Specimens

The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the special controls guideline entitled Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens. These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.

FDA Issues Not Approvable Letter to Epigenomics for Colorectal Cancer Test

EpiGenomics said that it has received a "not approvable letter" from the US Food and Drug Administration for its Epi proColon screening test for colorectal cancer. According to the Berlin, Germany-based molecular diagnostics firm, "the FDA determined that while the studies performed so far have established the clinical performance characteristics of the test, the [Premarket Approval] application does not yet contain sufficient evidence to warrant an approval for Epi proColon." Specifically, Epigenomics said that the FDA is seeking additional data demonstrating that the test will increase compliance to colorectal cancer screening in its intended use population, which are those patients who currently don't undergo CRC screening by guideline-recommended methods, such as colonoscopy or fecal immunochemical testing. 

Physicians Use Fitness Trackers to Monitor Patients in Real-time, Even as Developers Work to Incorporate Medical Laboratory Tests Into the Devices

Swift advances in technology devoted to fitness-tracking devices used by consumers are creating opportunities for physicians to tap that data to remotely monitor their patients. These pioneering efforts show how even medical laboratory testing functions might eventually be incorporated in these fitness tracking products. Of course, these devices were created for non-clinical functions. But they do allow doctors to get real-time looks at a patient’s vital signs outside of the traditional office visit. Using these consumer electronic devices for medical purposes is part of the larger trend of marshalling technology to produce better patient outcomes and reduce healthcare costs. 

Many PAs Noncompliant With HIV Screening Recommendations

Physician assistants' knowledge of and compliance with the CDC's routine universal HIV screening guidelines varies by specialty, according to researchers. “In order for health-care providers to assist in preventive efforts and provide appropriate care to those living with HIV, it is imperative to increase PAs understanding of HIV testing and guidelines provided by the CDC,” said Mary E. Springston MSEd, PA-C, during a poster session at the American Academy of Physician Assistants 2014 IMPACT meeting.

Roche to Pay Up to $350 Million for DNA Sequencing Business

Roche, the Swiss drug and health care diagnostics maker, said that it would pay as much as $350 million for Genia Technologies, a privately held DNA sequencing company. The addition of Genia’s technology is expected to strengthen Roche’s “next generation sequencing pipeline,” Roland Diggelmann, the chief operating officer of the Roche Diagnostics unit, said in a statement. Genia, founded in 2009, is developing proprietary technology that is expected to reduce the price of DNA sequencing while increasing the speed and sensitivity of such sequencing, Roche said.

Hidden Novel Proteins Found That May Aid Against Disease

Scientists have discovered 193 hidden human proteins in an initiative that has produced the first comprehensive map of the human proteome, a research tool that may help drive new findings against disease. Proteins are complex molecules that carry out the instructions of genes, performing the work needed to build and regulate the body’s tissues and organs. A directory of the body’s proteins may help refine research in diagnostics and drug development, building on the work from the Human Genome Project years earlier, the scientists said. The research, reported in the journal Nature, studied tissue from both adults and fetuses, potentially opening a new window into diseases that begin early in life. The 193 novel proteins identified were a surprise, found in regions of the genome not normally thought to include them. “Some of the proteins expressed during development in ovary and testis can serve as potential biological markers for identifying cancers of different lineages in the future,” the researchers wrote in the paper.

Promising Discovery in the Fight Against Antibiotic-resistant Bacteria

Researchers at the University of British Columbia have identified a small molecule that prevents bacteria from forming into biofilms, a frequent cause of infections. The anti-biofilm peptide works on a range of bacteria including many that cannot be treated by antibiotics. "Currently there is a severe problem with antibiotic-resistant organisms," says Bob Hancock, a professor in UBC's Dept. of Microbiology and Immunology and lead author of the study published in PLOS Pathogens. “Our entire arsenal of antibiotics is gradually losing effectiveness.”

Hancock and his colleagues found that the peptide known as 1018 - consisting of just 12 amino acids, the building blocks of protein - destroyed biofilms and prevented them from forming. Bacteria are generally separated into two classes, Gram-positives and Gram-negatives, and the differences in their cell wall structures make them susceptible to different antibiotics. 1018 worked on both classes of bacteria as well as several major antibiotic-resistant pathogens, including E. coli,Pseudomonas aeruginosa and MRSA.
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Nobel Laureate-led Team Using Genetics to Prospect for Cattle Viruses With Possible Colorectal Cancer Links

A German team led by Nobel Laureate Harald zur Hausen is using DNA and RNA sequencing as part of its search for unknown animal pathogens with possible roles in human cancer. In particular, zur Hausen — a German Cancer Research Center investigator best known for discovering a role for high risk human papillomaviruses in cervical cancer — contends that the consumption of beef-borne viruses carried by some types of cattle could theoretically be contributing to rising colorectal cancer rates in some countries. Roughly one-fifth of cancer cases worldwide are linked to some manner of infectious event, zur Hausen explained, from hepatitis B viruses causing liver cancer and high-risk forms of HPV in cervical cancer to bladder cancer-causing schistosome parasites. Along with looking at types of cancer that are more or less common in individuals with immunosuppression, he argued that there may be situations where infectious agents are behind apparent nutritional cancer risks.

Chronic Inflammation Linked to High-grade Prostate Cancer

Men who show signs of chronic inflammation in non-cancerous prostate tissue may have nearly twice the risk of actually having prostate cancer than those with no inflammation, according to results of a new study led by researchers from the Johns Hopkins Kimmel Cancer Center. The link between persistent inflammation and cancer was even stronger for men with so-called high-grade prostate cancer — those with a Gleason score between 7 and 10 — indicating the presence of the most aggressive and rapidly growing prostate cancers. “What we’ve shown in this observational study is a clear association between prostate inflammation and prostate cancer, although we can’t prove that inflammation is a cause of prostate cancer,” said Elizabeth A. Platz, Sc.D., M.P.H., a professor in the Department of Epidemiology at the Johns Hopkins University Bloomberg School of Public Health and in the School of Medicine.

1 in 4 Smokers With Gene Defect May Get Lung Cancer

Study finds smokers with gene normally linked to breast cancer appear to have a much higher risk of lung cancer. Up to one in four smokers with a particular genetic defect will develop lung cancer, researchers report. "Smokers in general have nearly a 15 percent chance of developing lung cancer, far higher than in nonsmokers. Our results show that some smokers with BRCA2 mutations are at an enormous risk of lung cancer -- somewhere in the region of 25 percent over their lifetime," said study leader Richard Houlston. He's a professor of molecular and population genetics at the Institute of Cancer Research in the United Kingdom.

Fully Automated Artificial Pancreas Finally Within Reach

Even with increasingly effective treatments and glucose monitors, most individuals with type 1 diabetes still cannot achieve recommended glucose control goals. Many experts believe that the best near-term solution for patients will be a system that can independently restore insulin and glucose balance. “Artificial pancreas systems will be the most revolutionary advance in diabetes care since the discovery of insulin,” said Aaron Kowalski, PhD, a vice president at the Juvenile Diabetes Research Foundation (JDRF), a global organization that funds type 1 diabetes research. An artificial pancreas is based on a simple concept: an automated system to dispense insulin and other pancreatic hormones based on real-time changes in blood sugar levels. But researchers face numerous challenges in turning the concept into reality.
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Autism Linked to 'Male Hormones'

Exposure to high levels of "male" hormones in the womb increases the chance of a baby boy developing autism, according to researchers. The University of Cambridge researchers say their findings from more than 300 boys help unravel the causes of autism - a condition that affects both sexes but is far more common in males. But they say it does not mean a prenatal test for autism is near. Nor will it necessarily be possible to stop autism by blocking the hormones. Because some of these hormones are produced in much higher quantities in males than in females, this may help us explain why autism is more common in males” The hormones in question - testosterone and three other steroid hormones - were important for foetal development, which meant it could be too risky to block them, they told the journal Molecular Psychiatry.

The Genetics of Preterm Birth: True Labor or False Labor?

Most women with threatened preterm labor between 20 and 37 weeks’ gestation will go on to complete their pregnancies. However, a small percentage of women will have a spontaneous preterm birth. Scientists looking to better predict who is most at risk for having a spontaneous preterm birth have turned to studying genes in the hopes that a blood test may provide an answer. In analyzing the differentially expressed genes from the blood samples, the researchers discovered that a set of nine genes, coupled with clinical blood data, could classify whether 70% of participants would or would not have a spontaneous preterm birth within 48 hours of hospital admission. Lye and his colleague Jan Heng, PhD, unveiled the results in the journal PLOS ONE.

World's Best Thermometer Made From Light 

Univ. of Adelaide physicists have produced the world's most sensitive thermometer — three times more precise than the best thermometers in existence. Published in the journal Physical ReviewLetters, the researchers from the university's Institute for Photonics and Advanced Sensing (IPAS) report they have been able to measure temperature with a precision of 30 billionths of a degree. "We believe this is the best measurement ever made of temperature − at room temperature," says project leader Prof. Andre Luiten, Chair of Experimental Physics in IPAS and the School of Chemistry and Physics, pointing out that it is possible to make more sensitive measurements of temperature in cryogenic environments near absolute zero. The paper - Nano-Kelvin Thermometry and Temperature Control: Beyond the Thermal Noise Limit - describes a new and very sensitive, but unorthodox, thermometer that uses light to measure temperature. PhD candidate Wenle Weng carried out the work. Luiten says the researchers have developed a new technique that could be redesigned for ultra-sensitive measurements of other things such as pressure, humidity, force or searching for a particular chemical.
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Amber Discovery Indicates Lyme Disease is Older Than Human Race

Lyme disease is a stealthy, often misdiagnosed disease that was only recognized about 40 years ago, but new discoveries of ticks fossilized in amber show that the bacteria which cause it may have been lurking around for 15 million years – long before any humans walked on Earth. The findings were made by researchers from Oregon State University, who studied 15-20 million-year-old amber from the Dominican Republic that offer the oldest fossil evidence ever found of Borrelia, a type of spirochete-like bacteria that to this day causes Lyme disease. They were published in the journal Historical Biology. In a related study, published in Cretaceous Research, OSU scientists announced the first fossil record of Rickettsial-like cells, a bacteria that can cause various types of spotted fever. Those fossils from Myanmar were found in ticks about 100 million years old.

Syphilis Rising in a Connected Age

Syphilis, by its nature, should be a relatively easy public health problem. Humans are the only reservoir, for the most part it's transmitted sexually, and it's relatively easy to cure. Why, then, is the rate of syphilis rising in the U.S.? Specifically, why is it rising mainly among gay and bisexual men, while dropping in most other groups? And why is it rising now, rather than, say, a decade ago? It's a combination of factors, according to experts who spoke to MedPage Today.

CDC: Measles Cases in USA Hit 20-year High

The USA has the most measles cases in 20 years and the most since homegrown outbreaks were eliminated in 2000, the federal Centers for Disease Control and Prevention announced. The confirmed case count for 2014, as of May 23, was 288 and growing, the CDC says. The nationwide total is the highest for late May since 1994, when 764 cases were reported, the CDC says. It surpasses the 220 cases reported in all of 2011, which was the most in the post-2000 era. "This is not the kind of record we want to break, but should be a wake-up call for travelers and for parents to make sure vaccination records are up to date," said Anne Schuchat, director of the CDC's National Center for Immunizations and Respiratory Diseases. Schuchat, who spoke during a telephone news conference, said this year's outbreaks are occurring among unvaccinated clusters of people exposed to travelers bringing the measles virus back from other countries — most notably the Philippines, where a large outbreak began in October 2013.

See Doctor Before Heading to the World Cup: Health Officials

Before heading to Brazil for this month’s World Cup or the 2016 Olympic Games, people should visit their doctors for appropriate preventive medicine, U.S. health officials say. Those visiting Brazil should see their doctors or travel medicine specialists four to six weeks before traveling, researchers from the U.S. Centers for Disease Control and Prevention (CDC) in Atlanta write inJAMA Internal Medicine. “We’re expecting that a lot of Americans will attend and we want to give them a chance to review some of the health and safety issues that come with attending World Cup-like events in a country like Brazil,” said Joanna Gaines, a senior epidemiologist at the CDC and lead author of the statement. The CDC has already issued a travel advisory for U.S. citizens heading to the World Cup, which takes place in 12 cities throughout Brazil between June 12 and July 13 (see:1.usa.gov/1mKeX2IExternal Web Site Icon).
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Funding Superbug Research is Critical

Though largely preventable, C. diff. claims at least one American every 19 minutes. And someone in the U.S. contracts a C. diff. infection (CDI) every minute. In late 2013, the CDC classified CDIs as one of three most "urgent" health threats facing the nation and requiring aggressive action. That's why approving the president's proposal for an additional $44 million for the Centers for Disease Control (CDC) in the 2015 budget is a must for public health. The proposal would help scientists tackle the most dangerous superbugs, including CDIs. In specific, $30 million in increased funding would establish regional laboratory networks to better detect drug-resistant threats in the community and in hospitals. It would also create a drug-resistant bacteria bank where companies could access samples to test new diagnostics or antibiotics. And it would set up a public-access data portal with information on drug-resistant infections, along with an overdue study to look at the long-term impact of antibiotics in young children. Research indicates more than 90 percent of CDIs are linked to health care settings. CDC leaders believe the new investment would decrease health care-associated CDIs by 50 percent over the next five years.

Restaurants, Food Service Workers Can Prevent Norovirus, CDC Says

Norovirus outbreaks on cruise ships may grab headlines, but contaminated food served by restaurants sickens many more people, federal officials said. The Centers for Disease Control and Prevention said that nearly one-third of the 20 million people sickened every year are poisoned by contaminated food. Waiters, cooks and other handling meals cause two-thirds of food-related outbreaks. "Norovirus outbreaks from contaminated food in restaurants are far too common." said Dr. Tom Frieden, director of the CDC.

 FDA Launches Data Platform

The Food and Drug Administration is opening up information on adverse drug events for developers who want to build applications using the data. It's a big step in a larger effort, dubbed openFDA, to create an open-source platform for information on the medications and devices the agency regulates. OpenFDA is an application programming interface (API) that connects agency data to developers who want to build applications that harness FDA information. The data, which covers 2004 to 2013, is stripped of any personally identifiable information and can be searched in a variety of ways. There are structured unique identifiers for drugs and ingredients, but officials also felt it was important to have unstructured access to the information, said Dr. Taha Kass-Hout, the FDA's chief health informatics officer. Developers can build apps that give access to drug information by trade name, generic name or other information, and openFDA allows for misspellings. "This is a beta release," Kass-Hout said. "We have plenty of disclaimers not to use this for clinical decisions." 
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Big Data Lacks Demonstrated 'Real-world' Value

Big data will not reduce costs or improve care unless the industry overcomes challenges around standards and methods, according to a report from the national health policy institute Network for Excellence in Health Innovation (NEHI). Priorities going forward, according to the report, include:
  • Clarifying policy on access to emerging real-world data sets for research.
  • Promoting transparency in communication and use of comparative effectiveness research (CER) and real-world data.
  • Defining and measuring value in ways that recognize the variability in treatment effects among patients.
  • Developing high-quality data and sound research methods in new CER that relies on electronic claims and clinical data.

Consumer Health Data Needs Better Protection, FTC Says

Congress needs to force data brokers to be more transparent about how they use the personal information of consumers--including health information--the Federal Trade Commission said in a new report published. The FTC recommends that Congress act to protect such sensitive data by requiring that brokers collect information only after obtaining consumer consent. "Because few consumers know about the existence of data brokers, meaningful notice from the data source provides an important opportunity for consumers to learn that their data is shared with data brokers and how to exercise control over the use of their data," the report's authors wrote.

Common Health IT Threats for Physicians to Consider

As more providers, business associates, and subcontractors engage in HIPAA risk analysis and risk assessments, it is important to appreciate where vulnerabilities lie in relation to health IT systems and what should be addressed in some of the required medical practice policies and procedures, including contingency and notification plans. Below are some of the common threats that physicians and all other entities covered under HIPAA should address:
  • Natural disasters;
  • Computer viruses;
  • Deliberate attack;
  • Non-disaster downtime;
  • Unauthorized access;
  • Data integrity loss; and
  • Communication loss.
As a practice, did you know that a contingency plan is required by HIPAA? If your practice has a contingency plan, does it address all potential scenarios related to adversely impacting the integrity, confidentiality, and availability of PHI? Taking precautions now can greatly reduce the risk of IT threats, fines, and breaches. 

Federal Inmates to Get More Advanced Electronic Health Records

The Bureau of Prisons is starting to shop around for a new electronic health record system for federal inmates. The federal prison system already has a basic EHR -- the Bureau Electronic Medical Record, which has been in place in 2006, handles inmate data, prescription drug information, and supports some more advanced functions, including telemedicine for X-rays. The BOP now appears to be scoping out a more advanced system that includes clinical decision-making capabilities, mobility, infectious disease outbreak management, and compliance with meaningful use guidelines promulgated by government and industry. The RFI makes no mention of whether an inmate's health record should be portable and can follow an inmate into the private or government health care system upon his or her release from custody. But the bureau is interested in learning from vendors whether their commercial EHR systems are interoperable with existing third-party systems. 

Report Shows $6.7 Billion in Improper Medicare Payments

Medicare paid out $6.7 billion in 2010 for health care visits that were improperly coded or lacked documentation, a report released found. That's 21% of Medicare's total budget for diagnostic and assessment visits, according to the Department of Health and Human Services inspector general. They found that 42% of diagnostic and assessment claims were improperly coded and 19% were improperly documented. While many of the coding issues may be due to legitimate errors, they tended to be in the provider's favor: 

3 Doctors Billed Medicare for 24,000 Tests for 145 Patients

Three Connecticut doctors billed Medicare for nearly 24,000 drug tests in 2012 – on just 145 patients. Despite the extraordinary number, Medicare administrators paid the doctors a total of $US1.4 million, according to a Reuters analysis of government payments to health providers. The three physicians stand out in the Medicare data released last month because they conducted three to four times more drug tests per patient than any other provider in the country. In fact, they ordered so many individual tests, their patients averaged one every other day. A surge in prescription drug abuse among older Americans has been accompanied by a big increase in urine and blood tests nationwide. Part of an effort to detect that abuse, the tests generate millions of dollars for providers. Medicare, the government insurance system for the disabled and people 65 years and older, is footing the bill.

Drug Diversion in Hospitals Exposes Patients to Infection

Health care workers diverting patients' pain medications for their own use have been linked to six infectious disease outbreaks over the last decade, putting thousands of patients at risk, according to a new report. The report published June 2 in Mayo Clinic Proceedings outlines infection outbreaks that have occurred in the past 10 years as a result of drug diversion -- the use of prescription drugs for unintended, illegal purposes -- committed by health care providers who stole or tampered with their patients' injectable medications.

U.S. Leadership for the Health Workforce We Need Post-2015

U.S. leadership to build momentum on renewed global action to address health workforce gaps started last year as the global health community was preparing for the Third Global Forum on Human Resources for Health in Recife, Brazil. In the lead up to the Forum, Dr. Ariel Pablos-Mendez, Assistant Administrator for Global Health at the U.S. Agency for International Development (USAID), spoke passionately during a United Nations General Assembly side event about the need to come together on a global strategy to build the health workforce needed to deliver crucial services post-2015.  According to the World Health Organization and GHWA, at least 83 countries lack sufficient health workforces to provide essential health services to their populations, and this doesn’t even account for equitable access issues within countries. WHO and GHWA estimate at least 7.2 million doctors, nurses and midwives are currently needed globally – a gap that could creep to nearly 13 million by 2035 if we keep with the status quo.

Pathologists and Medical Laboratory Scientists in India Call for Active Government Regulation in Response to Ongoing Problems With Quality of Medical Laboratory Tests

In the $5 billion a year Indian diagnostics laboratory industry, only 1% of laboratories are accredited. Pathology and clinical laboratory testing in India is growing at a double-digit pace. However, pathologists and medical laboratory scientists are raising the alarm about a disturbing lack of quality and accuracy that exposes patients to unnecessary harm. In fact, there are loud voices within the pathology profession in India who are urging government officials to more actively regulate the country’s diagnostics industry, according to a story published by the Business Standard, a national newspaper in India.
Source: http://www.darkdaily.com/External Web Site Icon


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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