viernes, 7 de febrero de 2014



Healthcare News

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


February 06, 2014

View Previous Issues - Healthcare News Archive

New Rule Allows Patients to get Test Results Directly From Labs, Without Doctors’ Clearance

Patients may obtain their test results directly from the laboratory that produced them, without having to go through their doctors first, under regulations announced by the Obama administration. The ruleExternal Web Site Icon is part of a broader effort by the administration to give Americans more control over their health care. It supersedes state law and will have particular significance in 13 states that forbid labs from releasing test results directly to patients. Consumer groups cheered the rule, saying it will empower patients and reduce mistakes. A 2009 study in the Archive of Internal Medicine found that providers failed to notify patients of abnormal test results 7 percent of the time. Other estimates have put that rate higher. The American Medical Association and the American Association of Family Physicians, two large physicians groups, had raised concerns that allowing patients to get their test results without a doctor’s help in understanding them could do more harm than good. 


Deadly New Bird Flu Strain Spawned by Virus Behind H5N1

The new bird flu that’s infected two people in China, killing one, was spawned by the same pathogen that produced two other deadly flu strains, a study found. The H10N8 strain, which hasn’t previously been reported in humans, contains six out of eight genes from the H9N2 virus that also provided the genetic foundation for the H5N1 virus that’s killed 386 people since 2003, and the H7N9 strain that led to at least 70 fatalities, Chinese researchers wrote in The Lancetmedical journal.


FDA Mulls Faster OK for High-Need Devices

The FDA wants to create an expedited approval pathway for high-risk medical devices for unmet needs, saying current tools at its fingertips are ineffective for speedier approvals. The change the agency is considering would create more post-approval studies for products and bring more uncertain devices to the marketplace, Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health in Silver Spring, Md., said Thursday.


Medicare Bill Focuses on Treating Chronic Illnesses

A new bipartisan bill in Congress proposes a bold, even whizbang approach to caring for Medicare's sickest, most expensive patients — those with multiple chronic illnesses. The Better Care, Lower Cost Act resorts to traditional managed-care tools such as risk-adjusted capitated payments to clinicians, but also promotes the use of high-tech tools; including telemedicine in rural areas, remote monitoring, and smartphone apps that help patients better manage their conditions. Healthcare providers would voluntarily form multidisciplinary teams — possibly partnered with hospitals — that would enjoy important advantages over accountable care organizations (ACOs) in rendering coordinated, cost-effective care to seniors with chronic illnesses, according to the bill's sponsors. Sen. Ron Wyden (D-OR) and Sen. Johnny Isakson (R-GA) introduced the bill in their chamber on January 15 while Rep. Erik Paulsen (R-MN) and Rep. Peter Welch (D-VT) sponsored identical legislation in the House.


CDC: Other Countries' Health Threats Can Affect U.S.

The Centers for Disease Control and Prevention warned that just because there’s a disease outbreak overseas, doesn’t mean people on U.S. shores won't be affected. On a conference call with media, the CDC emphasized that the threat of global infection is real, especially with widespread worldwide travel approaching due to the Winter Olympics in Sochi and Chinese New Year well underway. Dr. Tom Frieden, the CDC's director, said that there are three main threats the agency has identified, in order): new and emerging pathogens such as H7N9 bird flu and the plague, drug resistance, including some strains of tuberculosis, and intentionally created bioweapons. The Jan. 31 edition of the CDC's journal, Morbidity and Mortality Weekly Report, included two articles that focused on global health security projects in Uganda and Vietnam. The programs provide good models for potential plans, and Frieden emphasized that it is important for the U.S. to work with foreign nations in order to promote global health. 


Public Health Genomics Highlights 2013

At the end of each year, we read about top lists of major events, accomplishments, and milestones. These lists are produced by journal editors, institutions and opinion leaders. CDC is no exception. Our top 5 list focuses on events and issues that illustrate how the use of genomic information is making a real impact on improving health and preventing disease in populations. We are interested in our readers’ opinions and input on these issues and others that we may have left out.
1- 50 Years of Newborn Screening: Saving Lives and Preventing Disease & Disability—2013 year marked 50 years of saving lives through newborn screening. 
2- 10 Years of Family Health History: As Important as Ever—2013 marked the 10th anniversary of Family Health History Day on Thanksgiving. 
3- Pathogen Genomics and Public Health: The Time is Now—Pathogen genomics is already on CDC’s top 5 list for 2013, and it is noteworthy on the public health genomics list.
4- Whole Genome Sequencing in Healthcare: Great Promise and Great Challenges—We are now formally in the era of Next Generation Sequencing (NGS) which includes many applications such as exome sequencing, gene panels, and whole genome sequencing (WGS).
5- Policy and Legislative Actions Affecting Implementation of Genomic Medicine—In 2013, several branches of the US government enhanced implementation of validated genomic applications through significant policy and legislative activities while curtailing the premature use of such technologies. These included: the Supreme Court ruling on gene patents; the FDA authorization of the first, next-generation DNA sequencer; the FDA’s increased regulatory activity over the direct-to-consumer genetic testing industry; the Affordable Care Act provisions for coverage of some genetic counseling and testing; and the progress in implementation of genomics objectives in the Healthy People 2020 initiative. 


AACC Offers Certificate Program on Regulatory Affairs for Laboratory Compliance

In six courses, this AACC certificate program provides an overview of:
  • Regulatory oversight
  • The effect of CLIA ’88, OSHA, and HIPAA on clinical lab operations
  • Fraud and abuse provisions
  • The laboratory reimbursement process
  • Regulation of diagnostic tests by the FDA
  • Resources available for meeting state and private requirements


Ethics Questions Arise as Genetic Testing of Embryos Increases

Genetic testing of embryos has been around for more than a decade, but its use has soared in recent years as methods have improved and more disease-causing genes have been discovered. The in vitro fertilization and testing are expensive — typically about $20,000 — but they make it possible for couples to ensure that their children will not inherit a faulty gene and to avoid the difficult choice of whether to abort a pregnancy if testing of a fetus detects a genetic problem. But the procedure also raises unsettling ethical questions that trouble advocates for the disabled and have left some doctors struggling with what they should tell their patients. When are prospective parents justified in discarding embryos? Is it acceptable, for example, for diseases like GSS that develop in adulthood? What if a gene only increases the risk of a disease? And should people be able to use it to pick whether they have a boy or girl? A recent international survey found that 2 percent of more than 27,000 uses of preimplantation diagnosis were made to choose a child’s sex.


Trends in Laboratory Test Volumes for Medicare Part B Reimbursements, 2000–2010

The study provides evidence–based literature showing real trends in laboratory testing, which can confidently be used in the health policy arena. Their study, heavy with data and charts, is a good example of the kind of literature – evidence–based – that needs to be produced to most effectively inform health policy. Patients older than 65 years are a major sector of the health care population, and a significant number of laboratory tests are performed on that population; therefore, this study is a very reasonable proxy for laboratory testing performed in all older patients. For the purposes of informing health care policy arguments, the study’s data and explanations regarding changes in the ordering of laboratory tests is extremely valuable. Pathologists have long understood the value of evidence–based medical literature; in fact, modern pathology practice depends on it. 


Home Screening Test Detects 79% of Colorectal Cancers

An inexpensive, home-based test could be a good way to get more Americans screened for colorectal cancer, the country's second-leading cause of cancer death, a new study suggests.
Screening patients with a single FIT – or fecal immunochemical test – detected 79% of colorectal cancers, according to a report in Annals of Internal Medicine. That compares well to colonoscopies, which find about 90% of colorectal cancers, says lead author Jeffrey Lee, a post-doctoral researcher at the Kaiser Permanente Division of Research in Oakland and the University of California, San Francisco.


Beating the Poppy Seed Defense: New Test Can Distinguish Heroin Use From Seed Ingestion

Is the death knell about to sound for the infamous “poppy seed defense”? Heroin is one of the most widely used illegal drugs in the world, but drug testing has long been challenged by the difficulty of separating results of illicit heroin users from those who have ingested poppy seeds containing natural opiates. Research published in Drug Testing and Analysis explores a new test which may provide an answer.


A Simple Blood Test Can Predict Diabetes Risk Much Earlier

Dr. Nataly Lerner of Tel Aviv University's Sackler Faculty of Medicine and her colleagues have discovered that a simple blood test reveals an individual's risk of developing type-2 diabetes before they develop either condition - far earlier than previously believed. The findings, published in the European Journal of General Practice, could help doctors provide earlier diagnosis and treatment. Dr. Michal Shani and Prof. Shlomo Vinker of the Sackler Faculty of Medicine and Clalit Health Services collaborated on the study. "Our study supports the idea that the A1c test, used to diagnose type-2 diabetes, can also be used at a much earlier stage to screen for the disease in the high risk population, like overweight patients," said Dr. Lerner. As a bonus, the test is simpler to administer than the most common blood glucose tests, requiring neither fasting nor consuming anything.


Serum CRP Levels Linked to LUTS

Research from Taiwan shows that serum C-reactive protein (CRP) levels are associated with storage lower urinary tract symptoms (LUTS) and sensory bladder disorders. The researchers, led by Hann-Chorng Kuo (Tzu Chi University, Hualien), enrolled 853 men with benign prostatic hyperplasia and LUTS, with a mean age of 66.9 years and a mean serum CRP level of 0.31 mg/dL. In all, 430 (50.4%) patients had voiding predominant LUTS and 423 (49.6%) had storage predominant LUTS. The team found that serum CRP levels at baseline were significantly higher in patients with storage predominant LUTS than in patients with voiding predominant LUTS (mean 0.35 vs 0.27 mg/dL). Additionally, CRP level was associated with LUTS severity such that it was 0.40 mg/dL in those with severe LUTS compared with 0.28 and 0.31 mg/dL in those with moderate and mild LUTS, respectively.


Lethal Prostate Cancer Less Likely in Men With AB Blood

Men with blood group AB are less likely to develop lethal prostate cancer (PCa) than men with blood type O, researchers reported at the Genitourinary Cancers Symposium. Yuksel Urun, MD, of the Dana-Farber Cancer Institute in Boston, and colleagues prospectively evaluated the association between ABO blood group and risk of lethal PCa in the Health Professionals Follow-up Study from 1996-2008. A total of 2,793 cases of incidence PCa were documented during 12 years of follow-up of 26,602 men, including 289 lethal cases (either death from PCa or distant metastases). The frequency of ABO blood type was similar between men who developed PCa and other subjects.


IMPACT Study Supports Targeted PSA Screening Based on BRCA1/2 Mutations

Preliminary results from the initial screening round of the IMPACT study support the use of targeted prostate-specific antigen (PSA) screening based on BRCA genotype, which can yield “a high proportion of aggressive disease,” investigators concluded at the 2014 Genitourinary Cancers Symposium. The first year's results, for all men at study enrollment, “indicate that the majority of BRCA1 and BRCA2 mutation carriers diagnosed with prostate cancer at biopsy had developed clinical significantly disease, requiring radical treatment,” noted Christos Mikropoulos, MSc, of the Division of Genetics and Epidemiology at the Institute of Cancer Research, Sutton, United Kingdom, on behalf of the IMPACT Collaborators.


HPV At-home Tests Have a Future, Researchers Say

Certain tests can detect precancerous cervical cells from self-collected samples with nearly the same accuracy as a physician's swab taken in a clinic, according to a new review of past studies. Compared with those gathered by a physician, self-collected samples were about 11 percent less sensitive in identifying precancerous growth. However, the research team stops short of recommending at-home test kits as a cancer screening method for women infected with the sexually-transmitted human papillomavirus (HPV). Some strains of HPV are directly linked to cervical cancer risk, while others appear to have no negative effect on a woman's health. "We want the current screening programs to continue to run," said Marc Arbyn. "We do not want to promote self-sampling procedures over doctor's visits just yet," he said.


Concerns Unfounded: HPV Shot Doesn't Lead Teens to Sex

Add another study to a growing body of research showing that despite some parents' concerns, HPV vaccination does not lead teen girls to start having sex or to engage in unsafe sex. The latest, in the March issue of Pediatrics, published online, examines adolescent girls' and young women's risk perceptions or beliefs about the human papillomavirus (HPV) vaccine, whether accurate or inaccurate, and how they are linked to sexual behaviors up to six months after vaccination.


NCI Launches Study to Assess Using Sequencing to Help Guide Cancer Treatment

The National Cancer Institute said that it has launched a pilot study this month that will assess the clinical utility of treating cancer patients based on known pharmacogenetic mutations versus standard care. In the study, called the Molecular Profiling based Assignment of Cancer Therapeutics, or M-PACT, researchers will sequence the tumors of hundreds of patients for 391 different mutations in 20 genes known in the literature to impact response to various targeted therapies. The aim of the prospective, randomized study is to determine the degree to which cancer patients will benefit from treatments administered according to single pharmacogenetic mutations, compared to treatments given using non-genetic strategies. 


Colorado Team Developing Proteomic Profiles Linked to Learning and Memory

A team at the University of Colorado, Denver has identified protein profiles associated with learning in mouse models. Detailed in a paper published in Molecular & Cellular Proteomics, the effort is among the first to use proteomics to investigate the molecular underpinnings of learning, Katheleen Gardiner, a UC Denver researcher and senior author on the paper, told ProteoMonitor.


Exogen Bio Wants Your Blood to Test for DNA Damage

The DNA in our cells is subject to a lot of stress, and often the molecule breaks and becomes defective. There are mechanisms that exist to repair damaged DNA, but too often those are insufficient and the damaged DNA proliferates, potentially causing cancer and other diseases. Exogen Bio, a Lawrence Berkeley National Lab spin-off, has commercialized technology that can detect broken DNA strings in blood samples.


Lucigen Takes On Diagnostic Giants With On-the-Spot Pathogen Tests

Lucigen’s ambitious plan to challenge big diagnostic firms with its own rapid tests for infections like flu and strep traces its origins to a Yellowstone National Park hot spring dubbed “Octopus Spring.” That’s where molecular biologists David Mead and colleague Tom Schoenfeld in the early 2000s discovered an enzyme that will now form the key ingredient in their Middleton, WI, company’s planned test for quickly identifying pathogens.


Hospitals vs. MRSA: Pros and Cons of Screening All Patients

Should hospitals screen all inpatients for the potentially deadly methicillin-resistant Staphylococcus aureus (MRSA) superbug? Some infection control advocates say yes, pointing to the success of Veterans Affairs medical centers in controlling MRSA infections. Others argue that there are less costly ways to prevent the spread of the bacteria, which is resistant to antibiotics and often causes life-threatening bloodstream infections, pneumonia and surgical site infections. But it's hard to ignore the results of the VA's national MRSA Prevention Initiative. Prior to 2007, infection rates for MRSA at the Louisville (Ky.) VA Medical Center were 20 times higher than they are today, according to the Louisville Courier-Journal. 


Study Finds Changes in Brains of Hockey Players Who Had Concussions

Hockey players who sustained concussions during a recent season experienced acute microstructural changes in their brains, according to a series of studies published in the Journal of Neurosurgery. “We’ve seen evidence of chronic injuries later in life from head trauma, and now we’ve seen this in current players,” said Dr. Paul Echlin, an Ontario sports concussion specialist who conducted the study in collaboration with Dr. Martha Shenton of Brigham and Women’s Hospital and researchers from Harvard Medical School, Massachusetts General Hospital and Western University of Canada. The researchers said these were the first studies in which an independent medical team used magnetic resonance imaging analysis before, during and after a season to measure the effects of concussions on athletes. Forty-five male and female Canadian university hockey players were observed by independent physicians during the 2011-12 season.


Tackling Concussion Head On in the NFL

Action Points:
  • Studies suggest that the astroglial protein, S100B, may serve as a biomarker for diagnosis        of sports-related acute concussion.
  • Autoantibodies to S100B may serve as a marker of repeated blood-brain barrier disruption.
After decades of permitting on-field violent play, numerous well publicized cases of brain injury, and a multimillion dollar settlement with former players, the National Football League has begun making significant strides in improving the safety of the game and minimizing head trauma among players. "The publicity about concussion in football has had a huge impact, greatly increasing awareness that you have to treat head injury differently than injuries to any other part of the body and that there are dire consequences to mismanagement," said Robert C. Cantu, MD, co-director of Boston University's Center for the Study of Chronic Traumatic Encephalopathy, who is senior adviser to the NFL's Head, Neck, and Spine Committee.
Cumulative Hits to the Head
The focus also needs to extend to less severe head trauma. "The problem in my mind is that much of the focus has been on the big hits and not addressing the larger issue of the repetitive subconcussive brain trauma that occurs in many contact sports," said Robert A. Stern, PhD. There's now a large body of evidence implicating repetitive, subconcussive hits with long-term adverse consequences, including the neurodegenerative disease chronic traumatic encephalopathy (CTE), according to Stern. They also are trying to develop ways of diagnosing CTE other than at autopsy. 


Stem Cell 'Major Discovery' Claimed

Stem cell researchers are heralding a "major scientific discovery", with the potential to start a new age of personalised medicine. Scientists in Japan showed stem cells can now be made quickly just by dipping blood cells into acid. Stem cells can transform into any tissue and are already being trialled for healing the eye, heart and brain. The latest development, published in the journalNature, could make the technology cheaper, faster and safer.


Cells From Eyes of Dead 'May Give Sight to Blind'

Cells taken from the donated eyes of dead people may be able to give sight to the blind, researchers suggest. Tests in rats, reported in Stem Cells Translational Medicine, showed the human cells could restore some vision to completely blind rats. The team at University College London said similar results in humans would improve quality of life, but would not give enough vision to read. Human trials should begin within three years.


Scientists Find New Strategy to Combat Bacterial Infections

Increasing numbers of bacteria are developing antibiotic resistance. This forms a significant challenge in the battle against bacterial infections. Alvin Lo and Han Remaut (VIB/Vrije Universiteit Brussel) have identified a chemical substance with the potential of acting as a new drug to treat bacterial infections, particularly urinary tract infections. In contrast to the most popular antibiotics, this candidate drug does not destroy pathogenic bacteria, but rather disarms them. The benefit of this new strategy is that other (useful) bacteria are unharmed and there is a lower risk of the development and spread of resistance by bacteria. Many pathogenic bacteria attach to a cell before they can infect it, usually in a very similar manner. The research group led by Han Remaut has focused on a new approach in combating infections, which has succeeded in inhibiting this crucial step and thereby disarming the bacteria.


Anthrax Agent Killed by New, Unusually Large Virus

From a zebra carcass on the plains of Namibia in Southern Africa, an international team of researchers has discovered a new, unusually large virus (or bacteriophage) that infects the bacterium that causes anthrax. The novel bacteriophage could eventually open up new ways to detect, treat or decontaminate the anthrax bacillus and its relatives that cause food poisoning. The work is published in the journal PLOS One. The first thing the team noticed was that the virus was a voracious predator of the anthrax bacterium, said Holly Ganz, a research scientist at the University of California, Davis Genome Center and first author on the paper.


Food Bug Toxin May Trigger Multiple Sclerosis

New research presented at a scientific meeting adds to a growing body of evidence that a toxin produced by a common food bug may trigger multiple sclerosis, an inflammatory disease of the central nervous system. Dr. Jennifer Linden, a microbiologist at Weill Cornell Medical College in New York, presented the research at the 2014 ASM Biodefense and Emerging Diseases Research Meeting that is taking place in Washington, D.C., this week. "We provide evidence that supports epsilon toxin's ability to cause BBB [blood-brain barrier] permeability and show that epsilon toxin kills the brain's myelin producing cells, oligodendrocytes; the same cells that die in MS lesions." She and her colleagues also found that epsilon toxin targets other types of cells associated with MS inflammation, found in other parts of the central nervous system.


We Are Giving Ourselves Cancer

Despite great strides in prevention and treatment, cancer rates remain stubbornly high and may soon surpass heart disease as the leading cause of death in the United States. Increasingly, we and many other experts believe that an important culprit may be our own medical practices: We are silently irradiating ourselves to death. The use of medical imaging with high-dose radiation — CT scans in particular — has soared in the last 20 years. Our resulting exposure to medical radiation has increased more than sixfold between the 1980s and 2006, according to the National Council on Radiation Protection & Measurements. The radiation doses of CT scans (a series of X-ray images from multiple angles) are 100 to 1,000 times higher than conventional X-rays. 
Of course, early diagnosis thanks to medical imaging can be lifesaving. But there is distressingly little evidence of better health outcomes associated with the current high rate of scans. There is, however, evidence of its harms.


Obesity Is Found to Gain Its Hold in Earliest Years

For many obese adults, the die was cast by the time they were 5 years old. A major new study of more than 7,000 children has found that a third of children who were overweight in kindergarten were obese by eighth grade. And almost every child who was very obese remained that way. Some obese or overweight kindergartners lost their excess weight, and some children of normal weight got fat over the years. But every year, the chances that a child would slide into or out of being overweight or obese diminished. By age 11, there were few additional changes: Those who were obese or overweight stayed that way, and those whose weight was normal did not become fat. “The main message is that obesity is established very early in life, and that it basically tracks through adolescence to adulthood,” said Ruth Loos, a professor of preventive medicine at the Icahn School of Medicine at Mount Sinai in New York, who was not involved in the study.


Peanut Allergy Treatment 'a Success'

Doctors say a potential treatment for peanut allergy has transformed the lives of children taking part in a large clinical trial. The 85 children had to eat peanut protein every day - initially in small doses, but ramped up during the study. The findings, published in the Lancet, suggest 84% of allergic children could eat the equivalent of five peanuts a day after six months. Experts have warned that the therapy is not yet ready for widespread use. Peanuts are the most common cause of fatal allergic reactions to food. There is no treatment so the only option for patients is to avoid them completely, leading to a lifetime of checking every food label before a meal.


Vitamin Pills 'Lower Exercise Gains'

Taking some types of vitamin supplement may make it harder to train for big endurance events like marathons, researchers in Norway suggest. They said vitamins C and E should be used with caution as they may "blunt" the way muscles respond to exercise. However, actual athletic performance was not affected in the 11-week trial leading other experts to questions the research. The findings were published in The Journal of Physiology.


New Cream With Silver Nanoparticles Could Block HIV Transmission

According to the Centers for Disease Control and Prevention, more than 1.1 million people in the US are infected with human immunodeficiency virus. But new research has detailed the creation of a cream that has proved effective against transmission of the infection in laboratory tests. Previous research from the University of Texas, in collaboration with the University of Monterrey in Mexico, found that silver nanoparticles may be able to stop transmission of human immunodeficiency virus (HIV). Now, the research team has used the findings to create a vaginal cream that can block HIV transmission. Humberto Lara Villegas, of the University of Monterrey and co-author of the study, says that in order for HIV to infect immune cells of its host, a protein called GP120 helps the virus bond to the cells. He explains that the silver nanoparticles attach themselves to the GP120 protein and block it, meaning HIV is unable to infect immune cells.


Patient Classification is Complex, but Also a Big Deal

The wife of a retired Atlanta physician recently got a stunning lesson when her husband spent some time in a hospital. “We realized there might be a problem when he was not served breakfast along with the other patients,” she said. That was when they were told he had not actually been admitted to the hospital. “But he’s in a hospital bed, and he’s here in the hospital,” responded the wife. “Yes,” a nurse explained. “It can be confusing.” 
Hospitals may get an indirect financial benefit when they place people on observation status. For instance, a patient who is formally admitted to a hospital counts as a readmission if he or she has recently been discharged from that facility. An outpatient does not count as a readmission even if he or she has been discharged recently. This is important because readmission statistics affect a hospital’s bottom line. If the facility records a high number of Medicare patients being readmitted within 30 days of a discharge, it faces federal penalties on its reimbursements. As hospitals try to avoid the costly problem of too many readmissions, the patient may be caught in the middle.


Medical Homes Cut Unnecessary ER Use Dramatically

The use of medical homes with a low-income population in California dramatically reduced unnecessary hospital emergency room visits, California HealthLine reported. According to data compiled by researchers at the University of California at Los Angeles, low-income residents who enrolled and remained in medical homes were half as likely as those not in medical homes to use the ER for care that did not lead to a hospitalization.


Shortage of Saline Causes Hospitals, Dialysis Centers to Scramble to Manage Supply

A shortage of intravenous saline is causing hospitals and dialysis centers to scramble to manage their supplies of one of the most commonly used drugs. Healthcare providers are asking doctors and staff to use smaller IV bags and find alternatives, if possible, to cope with the shortage, officials and executives said. Officials have not yet heard of any facilities running out of the solutions, “but we know that hospitals are still reporting that they may only have a few days supply,” said Valerie Jensen, associate director of the drug shortages program at the Food and Drug Administration.


ACIP Issues 2014 Immunization Schedule for Adults

Updated vaccination recommendations for adults aged 19 years and older for 2014 have been released by the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization. The committee approved the Adult Immunization Schedule for 2014 in October 2013; the schedule was also reviewed and approved by the American Academy of Family Physicians, American College of Physicians, American College of Obstetricians and Gynecologists, and American College of Nurse-Midwives. 
The immunization schedule is being simultaneously published in the February 4 issue of the Annals of Internal Medicine and on the CDC's Web site. Additional guidance for the use of the vaccines and updates is also provided on the CDC's Web site.


FDA Making Adverse Medical Data Useful to the Public

Millions of Food and Drug Administration records on problems stemming from medication mistakes and other issues will be more readily available to the public under a recently announced initiative called “openFDA.”
The initiative will provide raw download access to the agency’s Adverse Event Reporting System, a database of reports on injuries and other complications stemming from use of medical products. The reports will also be accessible through application programming interfaces, software that allow developers to create programs using the government data.


CMS Not Doing Enough to Stop Medicare Fraud Linked to EHRs

The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently released a study entitled, “CMS and Its Contactors Have Adopted Few Program Integrity Practices To Address Vulnerabilities in EHRs,” which examined the failure of the agency implement up-to-date fraud techniques to address the shift from a paper to electronic records environment.   The OIG is recommending that CMS:
  • work with contractors to identify best practices and develop guidance and tools for detecting fraud associated with EHRs; and
  • direct its contractors to use providers' audit logs to distinguish EHRs from paper medical records when reviewing medical records.


Final Health IT Rule Could Facilitate Physician EHR Adoption

CMS recently published a final rule on its exception to the physician self-referral law that reflects concerns raised by the AAFP when the proposed rule was released last April. The final regulation,  “Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships: Exception for Certain Electronic Health Records (EHR) Arrangements” ( Adobe PDF fileExternal Web Site Icon was published in the Dec. 27 Federal Register and is effective on March 27. It revises the exception to a physician self-referral law that permits donation of EHR items and services in certain instances.


CCHIT Ending Testing and Certification of EHRs

The Certification Commission for Health Information Technology is getting out of the business of testing and certifying electronic health-record systems after nearly a decade as the first and still most-commonly used provider of those services in the U.S. The organization also stopped taking applications for testing and certification services from vendors and will finish work on about 70 of those systems it has in the pipeline and wind down that part of its operations by April or May, CCHIT Executive Director Alisa Ray said. Today, roughly half of all health IT systems on the official Certified Health IT Product List kept by the Office of the National Coordinator for Health Information Technology at HHS have been tested and certified by CCHIT.


Most Health IT Execs Unprepared for a Data Breach

Health IT executives aren't exactly prepared to weather any storm—most don't feel prepared for security breaches or unplanned outages, according to a new survey. More than half (56 percent) of the survey's respondents said they would need eight hours or more to restore 100 percent of data lost in a breach. The majority of the 283 health IT executives surveyed—82 percent—said that their technology infrastructure is "not fully prepared for a disaster recovery incident."


New To-do Lists Loom for 'Post-EHR Era'

As the electronic health record becomes "just another app," more and more providers are setting their sights on an array of complex future needs. IDC Health Insights' latest report sees big changes coming for care delivery in 2014 and beyond. As shown by the following 10 predictions from IDC, 2014 looks to be something of a pivot point, as provider IT departments start to look beyond the basic commodity of EHRs and toward a more complicated and demanding future.
  • First-generation EHR will continue to fail
  • The industrialization of healthcare will accelerate
  • Healthcare cloud adoption will flourish
  • The criticality of analytics will grow
  • Personalized clinical decision support will become closer to reality
  • Provider consolidation will continue
  • Revenue cycle management will become mission critical like never before
  • Underinvestment in business continuity will come home to roost
  • Security and privacy issues will drive providers to the private cloud
  • Compliance will cost you more than you think


Research Examines Impact, Trends of Health IT Since HITECH Implementation

A special February issue of the journal Health Services Research sponsored by the Office of the National Coordinator for Health IT examines the health information technology landscape, focusing on various trends and statistics, including adoption and performance. In a commentary introducing the issue, Rainu Kaushal, Director of the Center for Healthcare Informatics and Policy (CHiP) and a professor of medical informatics at Weill Cornell Medical College, and David Blumenthal, former National Coordinator for health IT and current president of the Commonwealth Fund, note that despite (or because of) the "huge growth" experienced by health IT since implementation of the HITECH Act in 2009, many questions remain about health IT's capabilities and impact.


ONC to Keep Tabs on HIE Reporting Requirement

Though federal funding for state health information exchanges is running out, the reporting burden won't end. The Office of the National Coordinator for Health Information Technology plans to continue to keep tabs on state HIEs by requiring a yearly report. It published a notice to extend its Information Collection Request authority for state HIE reporting beyond the current March 31, 2014, expiration date.


Medical Laboratory Leaders Gather in the United Kingdom to Address Challenges of Shrinking Lab Budgets and Need to Upgrade Quality Assurance Performance

Two major challenges in laboratory medicine were front and center this week when medical laboratory, a professionals and histopathologists gathered here in the United Kingdom (UK) for the eleventh annual Frontiers in Laboratory Medicine (FiLM). One challenge is how to improve the quality of lab testing services and demonstrate value to payers. The other challenge is how medical laboratories in the UK can cope with shrinking budgets for medical laboratories. 


Quest India Offers BRCAvantage Genetic Testing for Inherited Breast and Ovarian Cancers

Quest Diagnostics India announced the availability of BRCAvantage, a suite of lab-developed genetic tests (LDT) that identify mutations in BRCA1 and BRCA2 genes, which are associated with increased risk of inherited breast and ovarian cancers. The test offering in India follows Quest’s introduction of BRCAvantage to the United States in October 2013, and expands on the company’s goal to provide a wider menu of advanced cancer services in India.


Medical Errors on the Rise

The Kingdom is looking to develop a system of accountability for medical errors in the wake of an alarming increase in the number of such cases across the country. Many practitioners in the Kingdom get away with their mistakes simply because there is no mechanism in place for monitoring incidents of medical malpractice. 


In-patient Suicides and Other Medical Errors on the Rise: Productivity Commission

The annual number of serious medical errors made in Australian hospitals has increased from 87 to 107, a Productivity Commission report shows. These included 34 in-patient suicides, 35 instruments left inside patients and four cases of the wrong patient or body part operated on where it led to death or permanent injury. Experts say there is still more hospitals can do to prevent serious medical errors.
Source: Web Site Icon

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