A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
May 9, 2013
View Previous Issues - Healthcare News Archive
To all Interested Parties,
Evidence-Based Laboratory Medicine: Laboratory Medicine Best Practices Systematic Review Recommendations Evaluation
The Centers for Disease Control and Prevention, Division of Laboratory Science and Standards is pleased to announce a funding opportunity announcement (FOA) entitled Evidence-based Laboratory Medicine: Laboratory Medicine Best Practices Systematic Review Recommendations Evaluation. This grant funding opportunity is a cooperative agreement intended to evaluate the laboratory medicine best practices recommendation for reducing blood sample hemolysis rates developed through the Laboratory Medicine Best Practices ™ (LMBP ™) Initiative. To access the FOA, follow instructions below:
- Go to www.Grants.gov
- In the left menu bar, find Grant Opportunities and select this option
- Select Basic Search and use the Search by Funding Opportunity Number Option
- Enter the following funding opportunity number, CDC-RFA-OE13-1303
- Select the search button
Tennessee Governor Signs Exemption from State Laboratory Personnel Law
The legislation, SB1269, would broaden an exemption to the state laboratory personnel licensure law for laboratories that perform “advanced” biochemical, forensic, or toxicological testing. Several of the sponsoring organizations seeking the legislation sought to broaden the old exemption provided for forensic and compliance drug testing laboratories so that they could expand into the patient testing market. One of the entities reportedly involved with the bill, an oncology group practice, was seeking the exemption so that its Laboratory Developed Test would not have to use licensed laboratory personnel.
ASCP noted in its letter to the Governor that the measure would seemly allow exempt clinical laboratories to use laboratory personnel that did not satisfy the CLIA standards for high complexity testing. Opponents of the measure noted that the exemption was intended to benefit laboratories performing high complexity testing. ASCP noted that the personnel standards mandated by the bill would not require testing personnel to complete a baccalaureate degree with a major in a CLIA-recognized science, only a bachelor’s degree and 16 semester hours of academic science. As a result, the bill’s personnel standards fall below the CLIA high complexity testing requirements. But because of the way the measure was crafted, it is unclear that these laboratories could be held to the CLIA requirement.
Officials Prepare for Another Flu Pandemic — Just in Case
There's been a buzz of activity at the Centers for Disease Control and Prevention in Atlanta since scientists got their first samples of a new bird flu virus from China four weeks ago. Already they've prepared "seed strains" of the virus, called H7N9, and distributed them to vaccine manufacturers so the companies can grow them up and make them into experimental flu vaccine. They've also come up with a new diagnostic test for H7N9 that the Food and Drug Administration has approved on an emergency basis.
Dr. Daniel Jernigan, deputy director of CDC's influenza division, says there are two main reasons why H7N9 is getting so much attention. First, people who get it usually get very sick, and so far nearly a quarter of the 130 human cases have died. Second, the genetic makeup of this new virus is disturbingly different from an older bird flu virus.
U.S. to Delete Data on Life-Threatening Mistakes From Website
Two years ago, over objections from the hospital industry, the U.S. announced it would add data about “potentially life-threatening” mistakes made in hospitals to a website people can search to check on safety performance. Now the Centers for Medicare and Medicaid Services is planning to strip the site of the eight hospital-acquired conditions, which include infections and mismatched blood transfusions, while it comes up with a different set. The agency said it’s taking the step because some of the eight are redundant and because an advisory panel created by the 2010 Affordable Care Act recommended regulators use other gauges.
The decision to pull the measures is a retreat from a commitment to transparency, according to organizations representing employers that help pay for health insurance. “We have a right to know if hospitals are making errors that are catastrophic to patients,” said Leah Binder, president of the Washington-based Leapfrog Group, whose members include General Motors Co. and Verizon Communications Inc. “What they’re saying basically is hospital claims of unfairness have more weight than consumers’ right to know.”
U.S. Has Dropped to 10th Place in Medical Research Spending
To the ranks of civil rights and anti-war activists who've marched on Washington, get ready to add white-frocked scientists. Thousands of prominent cancer and other medical researchers will rally in the nation's capital to protest federal funding cuts that began several years ago and were accelerated by additional forced reductions beginning to take effect under the congressionally mandated process of sequestration. "It's really come on top of a fairly extended period of flat funding, which has eroded the purchasing power of biomedical dollars," said Roy A. Jensen, director of the University of Kansas Cancer Center, who will join the demonstration. "It's almost like the final push over the edge." Researchers say the pace of breakthroughs in treatment of cancer, HIV/AIDS and other major diseases will be slowed unless the decline is reversed.
The CMS released data showing U.S. hospitals charge widely varying amounts for the same services. The database, posted on the CMS website, is described as “part of the Obama administration's “work to make our healthcare system more affordable and accountable.” It includes hospital charges for 100 most frequently billed discharges by the more than 3,000 hospitals reimbursed under the inpatient prospective payment system. The charges for implanting a pacemaker, for example, range from about $20,000 to more than $200,000.
Are Smart Phones Smart Enough for Patient Care?
“Smart phones are starting to play a more central role in patient care. The challenge is to make sure that information is interpretable. Placing a complex amount of patient health information on the small screen of an iPhone may not be easy to read, let alone interpret.” “The question is: Are we creating patient safety issues by trying to push information out through a device that may not be optimized for this?” Dr. Tuthill asks. “Is the information potentially less secure because we’ve allowed it to be transmitted on a mobile device?” Healthcare clinicians increasingly struggle with these issues, especially as the U.S. Department of Health and Human Services (HHS) pushes for physicians to become more electronically savvy
Patients Most Annoyed by Long Waits, Unclear Test Results
Long waiting times and unclear test results are the top patient grievances when it comes to visiting the doctor, according to a report published in the June issue of Consumer Reports. The researchers found the top grievances to be: "unclear explanation of a problem" (8.1 out of 10); "test results not communicated fast" (7.9); "billing disputes hard to resolve" (7.8); "hard to get quick appointment when sick" (7.8); "rushed during office visit" (7.8); and "long wait for doctors in the exam or waiting room" (7.6).
Burnout Rampant in Healthcare
Survey reveals 60 percent of healthcare workers experience burnout
Heavy patient loads, smaller staffs and higher stress levels may be causing burnout among healthcare workers, according to a new survey by recruiting firm CareerBuilder. Harris Interactive conducted the online survey for CareerBuilder between February 11 and March 6, 2013, among more than 500 U.S. healthcare workers and more than 240 U.S. healthcare employers. A CareerBuilder spokesman said the data did not identify the type of healthcare worker responding – whether nurses and physicians giving direct care, or members of a health IT team, for example, providing a supportive role. More than a third (34 percent) of healthcare workers plan to look for a new job in 2013, up from 24 percent last year. Nearly half (45 percent) plan to look for a new job over the next two years. Eighty-two percent said that while they are not actively looking for a job today, they would be open to a new position if they came across the right opportunity.
Looser Guidelines Issued on Prostate Screening
In a major shift, the American Urological Association has pulled back its strong support of prostate cancer screening, saying that the testing should be considered primarily by men aged 55 to 69. The association had staunchly defended the benefits of screening men with the prostate test, even after a government advisory committee, the United States Preventive Services Task Force, said in 2011 that healthy men should not be screened because far more men would be harmed by unnecessary prostate cancer treatments than would be saved from death.
But in new guidelines, the urology association says that routine screening is no longer recommended for men 40 to 54 years old who are at average risk of getting prostate cancer. Screening is also not recommended for men 70 and older. The guidelines say men 55 to 69 should discuss the benefits and harms of screening with their doctors. And if they do choose screening, an interval of two years rather than annually would be better.
Preventing Pre-analytical Errors
Laboratory data influence 70% of medical diagnoses. This fact indicates that the laboratory is a major aid to the clinicians who have requested the tests. Furthermore, it means that the laboratory must try to reach the goal of zero defects. The testing process has been divided into three major parts (pre-, intra- and post-analytical), each with a few aspects that can be identified and, in many cases, quantified. Thus, the testing process lends itself to designing a systematic approach to error detection and correction, hopefully before data are reported. While some schemes include “choosing the test” as part of the pre-analytical phase, this article will not include it.
The pre-analytical phase is the most vulnerable part of the total testing process and is considered to be among the greatest challenges to laboratory professionals. Although a number of standards relating to blood sampling, sample transportation and handling are available, conformity is low. According to reliable data, pre-analytical errors still account for nearly 50% – 70% of all problems occurring in laboratory diagnostics. Although most of these errors are “intercepted” before inappropriate reactions are taken, in nearly 20% of cases they produce inappropriate investigations, including more unnecessary testing and, thus, unjustifiable increase in costs, while generating inappropriate clinical decisions and causing some unfortunate circumstances. For example, “Out of all laboratory problems, up to 61% are associated with the preanalytical phase in the lab. Out of this, 33% of the errors are associated with the test request forms, 18% errors with sample collection.”
Specimen Packaging, Shipping
Regulations governing the transport of biological and infectious substances have been around for approximately 25 years. As more shippers became compliant with these regulations, a more thorough analysis of the regulations’ effectiveness became available. Over time, the regulations have changed to adapt to an increased understanding of the nature and pathogenicity of infectious substances. Since publication in 2003, the regulations for the transport of biological and infectious substances have undergone a few minor revisions.
Half of Hepatitis C Patients Don’t Get Full Testing, CDC Says
Only 51 percent of people in the U.S. who test positive for hepatitis C received the necessary follow- up to determine if they require medical care, according to the Centers for Disease Control and Prevention. About 80 percent of people can’t fight off the virus that attacks the liver on their own. Without a follow-up, these patients may not get the health care they need, the Atlanta- based government health agency said in a report. A screening test shows if a person has ever been infected by the virus that usually spreads through contact with infected blood. If that antibody test is positive, a follow-up determines if the person is still infected and needs medical treatment. About 3.2 million people in the U.S. have hepatitis C, which can cause cirrhosis and liver cancer. The CDC recommends that people born from 1945 to 1965 get tested, as 75 percent of infected adults were born in this period.
Endocrinologists Make Call on Needle Biopsy
Endocrinologists can independently assess the quality of thyroid nodule biopsies in an office-based setting without the assistance of a cytopathologist, researchers reported. In a single-center study of patients undergoing fine-needle aspiration (FNA) for a thyroid nodule biopsy, nearly 97% of the 147 specimens were determined to be adequate by the endocrinologist and a cytopathologist, reported Saleh Aldasouqi, MD, of Michigan State University in East Lansing, and colleagues at the American Association of Clinical Endocrinologists meeting. "We are trying to improve the patient's experience as well as save some costs to the general healthcare system," Aldasouqi said during an AACE press briefing.
Gene Test Enhances Thyroid Biopsy
Genetic profiling of biopsies that can't be labeled benign or malignant on cytology testing may eventually diminish the number of surgeries needed, researchers reported. About half (48%) of the samples deemed suspicious on molecular testing in an office-based setting turned out to be malignant on the final pathology assessment after surgery, reported Brian Michael, MD, of Wellspan Endocrinology in Gettysburg, Pa., and colleagues during a presidential oral presentation session at the American Association of Clinical Endocrinologists meeting. "Use of [genetic analysis] should translate into fewer surgeries, decreased patient morbidity, and lower systemic costs," Michael said.
Digital slide imaging marks the future.
"With personalized medicine in our future, histologists are more important than ever to laboratory medicine." So says Mark Bailey, MA, HTL(ASCP)CM, assistant professor and program director for histotechnology students at the University of Texas MD Anderson Cancer Center School of Health Professions in Houston, TX. As a histology educator, Bailey sees the profession growing first-hand. "Since 2008, our program has increased enrollment up to 20% every year," he said. "At that time, we only had six students in the program. This year, we have 22." Next on the horizon for emerging technologies is digital imaging of slides, Bailey predicted. "In the last 5-8 years, there has been a very concentrated effort to develop algorithms to improve robotic microscopes that can image slides at a higher rate of speed and different magnifications," he said. "As histologists, we are experts in the management of tissue specimens and we have a vested interest in the development of these new technologies."
Gene Test May Help Predict Success of Weight-Loss Surgery
Weight loss after gastric bypass surgery varies widely, and scientists say they have identified a genetic variation that may help explain the discrepancy. The discovery, detailed in a study published May 2 in the American Journal of Human Genetics, is already driving creation of a gene test that may one day help patients predict how many pounds they might shed after weight-loss surgery.
Portable Cancer Diagnostic Device Adapted to Detect TB
Massachusetts General Hospital (MGH) investigators have modified a handheld diagnostic device, which was first developed to diagnose cancer, to rapidly diagnose tuberculosis (TB) and other important infectious bacteria. These portable devices combine microfluidic technology with nuclear magnetic resonance (NMR) to not only diagnose these important infections but also determine the presence of antibiotic-resistant bacterial strains.
No More Western Blots for Lyme Diagnosis?
Regardless of travel history, Lyme disease can be diagnosed with a two-tiered algorithm that employs a standard Lyme disease ELISA, followed by a newer-generation C6 peptide ELISA, a new study suggests. With the newer approach, "there is no requirement for cumbersome immunoblots, including IgM Western blotting, a test that has not fared well in the real world," said Dr. Robert Schoen from Yale University School of Medicine in New Haven, Connecticut in an editorial published with the study in Clinical Infectious Diseases.
Cancer Genetics Kidney Cancer Test Approved by CLIA, New York
Cancer Genetics said it has received CLIA and New York approval to offer its microarray-based kidney cancer test. As a result, the Rutherford, NJ-based firm has launched the test, called UroGenRA-Kidney, as part of its Kidney Complete Program. The test provides genomic data for differentiating the three malignant renal cell carcinoma subtypes — clear cell, papillary, and chromophobe RCC — from oncocytoma, a benign form of renal cancer.
Genetic susceptibility appears to play a role in Helicobacter pylori infection, a genome-wide association in two large studies showed. The toll-like receptor gene TLR1 was significantly associated with seroprevalence of the gastric bacteria, Markus Lerch, MD, of the University Medicine Greifswald, Germany, and colleagues reported. People with the highest levels of antigen to H. pylori suggestive of colonization were also in the top 25% for TLR1 expression levels (P=0.01), the researchers reported in the May 8 issue of Journal of the American Medical Association.
Mount Sinai Links EMR, Genomic Data
Mount Sinai Medical Center announced that 25,000 people have signed on to participate in its biobank program, BioMe, with each patient consenting to DNA sequencing and longitudinal studies related to data embedded in their electronic medical records. "Biobank participants represent the ancestral diversity of the local Upper Manhattan communities, with self-reported 25 percent of African ancestry, 30 percent of European ancestry, 36 percent of Hispanic Latino, and 9 percent of other ancestry," says Erwin P. Böttinger, MD, director of the Charles Bronfman Institute for Personalized Medicine at Mount Sinai. "To assess representativeness of the Biobank population for the local communities from which they are recruited, we obtained publicly available individual-level data from the annual New York City Community Healthy Survey, which provides robust data on the health of New Yorkers, including neighborhood, borough, and citywide estimates on a broad range of chronic disease and behavioral risk factors," he says.
Tiny Faroe Islands to Begin Sequencing Genomes of All 50,000 Residents in Ambitious Effort to Advance Personalized Medicine
Because of isolation from the worldwide DNA pool for the past 1,200 years, Faroese population is vulnerable to recessive gene disorders. Because of the dramatic—and still falling—cost of DNA sequencing, an ambitious project is launching with the goal of sequencing the full DNA of all 50,000 residents of the Faroe Islands. When completed, this project has the potential to reshape molecular diagnostics and clinical laboratory testing. FarGen is the name of this effort and pathologists and clinical laboratory managers will want to follow its progress.
FarGen Stirs Controversy about Use of Genetic Information
The Faroese parliament passed a law that requires use of a secure database to store the genetic data collected on its citizens, which is only available for clinical use. But just the same, the project has ignited a firestorm of debate over issues of privacy, ownership and the value of making patients’ complete DNA available to medical practitioners.
Helping Medical Technology Professionals Keep Pace With Regulatory and Compliance Issues
AdvaMed-MTLI and UL EduNeering have launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for Medical Technology Professionals. The ARCC Program is a relevant and timely collaboration between AdvaMed and UL EduNeering that helps medical technology professionals to expand their knowledge of quality, regulatory and compliance topics
Long Wait for Device Identifier Gets Longer
It's likely to be another seven weeks before the Food and Drug Administration finalizes long-awaited regulations that will require manufacturers to mark medical devices with unique identifiers that are expected to help track products during recalls, save money and improve patient safety. An FDA spokeswoman said in e-mail that the final rule would not be released in time to meet the May 7 deadline that was set in legislation passed last year. “We are working hard to complete this, and it is a priority for the agency,” she said.
The Food and Drug Administration is finally going to decide whether antibacterial soap actually works, or if it's causing more harm than good. The FDA's website currently states that "the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water." The American Cleaning Institute, a soap and detergent industry organization, says it has provided reams of data to FDA showing that triclosan is both safe and effective.
Safe Upper Limit of Vitamin D Identified for First Time
A new study examining more than a million individuals aged older than 45 years has, for the first time, verified an upper, safe limit for vitamin D in terms of mortality and cardiovascular events. The researchers also confirm the increased risk of death from suboptimal levels of the vitamin, corroborating the findings of many previous trials.
"In our large comprehensive database, we have determined the safe range of calcidiol blood levels and suggested a threshold for excess vitamin D, beyond which [our study participants] are at increased risk for…all-cause mortality and/or cardiovascular events. We defined a safe range of serum calcidiol of 20 to 36 ng/mL, and we found a U-shape association of the risk for [mortality or acute coronary syndrome] MACS and serum calcidiol," write Yosef Dror, PhD, from the Hebrew University of Jerusalem, Rehovot, Israel, and colleagues in their paper published online in the Journal of Clinical Endocrinology & Metabolism.
Dr. Dror told Medscape Medical News, "There is a crucial need to monitor serum calcidiol for the majority of the population."
C difficile: 10% of Patients Are Carriers at Hospitalization
One in 10 (9.7%) patients has asymptomatic Clostridium difficile (CD) colonization at the time of hospitalization, according to a new study. Surbhi Leekha, MBBS, MPH, from the Division of Infectious Diseases, Mayo Clinic, Rochester, Minnesota, and colleagues present their analysis of adults admitted to a tertiary care hospital in an article published in the May issue of the American Journal of Infection Control. Potential infection prevention measures to prevent CD transmission from asymptomatically colonized patients include contact precautions, hand hygiene with soap and water, and environmental cleaning with a sporicidal agent.
Warning System Predicts Outbreaks of Dengue Fever
With the help of a warning system which measures the risk of dengue incidence using precipitation and air temperature, it is possible to forecast the outbreak of dengue fever up to 16 weeks in advance. This is what Yien Ling Hii concludes in the dissertation she is defending at Umea University. Temperature and rainfall directly influence the biological development of mosquitoes. Higher temperature can accelerate mosquito development stages and increase dengue transmission; while rainfall produces more breeding sites for mosquitoes. "An early warning of disease outbreak can help local authorities and community to implement preventive measures such as eliminating mosquito breeding habitats to control or even prevent the outbreak from happening," says Yien Ling Hii.
International Group Settles on Name for New Coronavirus
In a move that may end more than 7 months of confusion, an international group of scientists and public health officials will soon recommend that the new virus be called Middle East respiratory syndrome coronavirus (MERS-CoV). The group plans to publish a paper recommending the new name, says Raoul de Groot, a veterinary virologist at Utrecht University in the Netherlands, who has coordinated the effort. De Groot chairs the Coronavirus Study Group of the International Committee on Taxonomy of Viruses (ICTV), which took the initiative to find a new, widely accepted name. The study group has no power to enforce use of the name, however; it will be up to researchers to decide whether to adopt the moniker.
News of the name comes as Saudi Arabia has reported 13 new cases of the virus, including seven deaths, in just the past 5 days
Borrowing a single gene from a human influenza strain can make a dangerous strain of bird flu easily transmissible between guinea pigs, researchers report in a paper published online in Science. The scientists conclude that there is a substantial risk that the strain, H5N1, which so far has not infected many people, could touch off a pandemic.
The paper is another example of so-called gain-of-function studies, a controversial field in which researchers deliberately manipulate viruses in ways that can make them more dangerous. Flu scientists argue that such studies are needed to better gauge pandemic risks
Virus's Toll in Saudi Arabia Raises Fears of Faster Spread
Saudi Arabia's announcements in the past five days of seven new deaths from a SARS-like virus have heightened fears that the Mideast outbreak is entering a more-aggressive phase. Security guards, their faces covered by green medical masks, stood watch outside the intensive-care unit at a small hospital in Hofuf, in the country's Eastern province, that is treating some of the victims in the most lethal surge yet of the year-old outbreak of a novel coronavirus. International public-health officials say they are as concerned about the coronavirus as they are about the new H7N9 avian flu virus that recently began sickening people in eastern China. The flu has hit more people—128 are known to have been infected as of May 2, including 26 who died—than the coronavirus.
Harvard Researchers Develop Novel Imaging Technique to Look at Embryo Formation, Find New Surprises
A team of researchers led by Sean Megason, Harvard Medical School assistant professor of systems biology, has shown through a novel imaging technique that our classic understanding of cell differentiation may be flawed. In a paper published in the April 25th issue of Cell, Megason and colleagues developed a data analysis technique that allows direct observation of the cells in an embryo as they move and change over time. They used it to see what happens in the embryo between the early and late snapshots. Based on the results of the technique, the researchers theorize that cell differentiation is in fact predetermined before being influenced by location-dependent factors. In other words, it is the cell itself that determines the differentiation, not the other way around as was previously thought.
‘Cured of AIDS’? Not Yet
What to make of all the recent “cured of AIDS” headlines? An American in Berlin, a baby in Mississippi and 14 patients in France are all alive without treatment.
Is a cure at hand? No. But in unusual cases, some people seem able, with temporary help from antiretroviral drugs, to kill the virus before it can sink into reservoirs deep in their bodies — or to at least force it to stand at the doorways of their cells, unable to get in.
“I’m excited about this,” said Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases. “Not that we’ve got a cure, but things are falling into place that tell us what goes into the process of infection. So we’re learning whom we can potentially take off treatment.”
One in Five Adults Meet Overall Physical Activity Guidelines
About 20 percent of U.S. adults are meeting both the aerobic and muscle strengthening components of the federal government's physical activity recommendations, according to a report published in Morbidity and Mortality Weekly Report, a journal of the Centers for Disease Control and Prevention. The data are based on self-reported information from the Behavioral Risk Factor Surveillance System; an annual phone survey of adults aged 18 and over conducted by state health departments.
The Physical Activity Guidelines for Americans recommend that adults get at least 2½ hours a week of moderate-intensity aerobic activity such as walking, or one hour and 15 minutes a week of vigorous-intensity aerobic activity, such as jogging, or a combination of both. The guidelines also recommend that adults do muscle-strengthening activities, such as push-ups, sit-ups, or activities using resistance bands or weights. These activities should involve all major muscle groups and be done on two or more days per week.
The suicide rate among middle-aged Americans rose 28% in a decade, a new report from the Centers for Disease Control (CDC) has found. Among adults 35-64, white people and American Indians saw the sharpest increases from 1999 to 2010. The CDC did not investigate causes behind the trend, but noted many suicide prevention programmes were geared towards youths and the elderly. The report found no significant change among other age groups. Since 2009, suicide has claimed more Americans than motor vehicle crashes. There were 38,350 suicides in 2010, making it the nation's 10th leading cause of death, the CDC said.
Feds Investigating Tenet's Atlanta Hospitals
Several Atlanta hospitals owned by Tenet Healthcare Corp. are being investigated by federal officials over potential kick-back violations. In filings with the Securities and Exchange Commission, Dallas-based Tenet (NYSE: THC) says it has received a subpoena from the Office of the Inspector General of the U.S. Department of Health and Human Services seeking documents from January 2004 through May 2012 related to the relationship that Atlanta Medical Center, North Fulton Regional Hospital, South Fulton Medical Center (now known as Atlanta Medical Center — South Campus) and Spalding Regional Hospital and Hilton Head Hospital (located in South Carolina) had with an unaffiliated company called Hispanic Medical Management Inc.
Researchers, Commonwealth Urge New Medicare Option
Researchers from the Johns Hopkins School of Public Health and the Commonwealth Fund are recommending a new Medicare public insurance option they say would combine parts of the decades-old federal health program and could reduce total health spending by $180 billion over 10 years. Called “Medicare Essential,” the plan from study authors Karen Davis, Cathy Schoen and Stu Guterman appears in the May issue of Health Affairs. It would blend Medicare's hospital, physician and prescription drug coverage into one integrated benefit with an annual limit on out-of-pocket expenses for covered benefits
AMA Says EHRs Create 'Appalling Catch-22' for Docs
As the healthcare industry moves to EHRs, the medical record has essentially been reduced to a tool for billing, compliance, and litigation that also has a sustained negative impact on doctors' productivity, according to Steven J. Stack, MD, chair of the American Medical Association’s board of trustees. “Documenting a full clinical encounter in an EHR is pure torment,” Stack said during the CMS Listening Session: Billing and Coding with Electronic Health Records.
EHRs are also driving the industry toward charts that look remarkably similar because they’re based on templates created by the technology vendors — that includes often using the same words. And that threatens to make doctors appear to be committing fraud by the practice of record cloning, or cutting and pasting from one record to another, when they are not, in fact, acting fraudulently.
EHR Dissatisfaction: A Tech or People Problem?
A percolating problem is beginning to boil over: doctors and nurses really don’t like their new electronic health records systems. And, as EHR implementations increase ahead of government deadlines for incentive dollars, dissatisfaction among clinicians is growing.
The problem might be that EHR implementation is treated as a purely technological issue when in reality it is a workforce issue. Several years before federal incentives began for healthcare providers to adopt EHRs, leading healthcare informatics organizations strongly recommended that workforce training and readiness must be a top priority in the national transformation from paper to electronic health records.
Anesthesiologist Robert Joseph, MD, interviewed several electronic health record vendors when researching which EHR system would work best for his small Florida clinic. He finally chose a software program called MyWay, sold by a subsidiary of Allscripts Healthcare Solutions, because it was designed to fit small and solo practices. But $40,000 and dozens of training hours later, the program has created headaches for Dr. Joseph's practice, he said. He claims that the system never worked effectively and failed to meet the federal regulatory requirements promised by Allscripts. Such problems have prompted a first-of-its-kind, class-action lawsuit against Allscripts by Dr. Joseph and three other practices. South Baldwin Family Practice LLC in Alabama, American Pain Care Specialists LLC in Florida and Advanced Pain Specialists in Missouri have joined Dr. Joseph's December 2012 suit on behalf of 5,000 physicians who purchased MyWay. Allscripts also faces a lawsuit over MyWay from Cardinal Health 200 LLC, which provides medical and surgical products to physician offices and others nationwide. In its February suit, Cardinal said it paid Allscripts $5 million for 1,250 licenses to sell MyWay to health professionals. Cardinal later discovered that the software was not compliant with ICD-10 and would not meet meaningful use requirements, the complaint said.
Hospitals Lose $8.3 Billion Using old Technology
U.S. physicians and hospitals are in the digital dark ages when it comes to using the latest mobile devices and Internet services to deliver patient care. As a result, U.S. hospitals are absorbing an estimated $8.3 billion annual hit in lost productivity and increased patient discharge times, according to a Ponemon Institute survey of 577 health care professionals, released to CyberTruth. Hospitals continue to struggle with security and privacy concerns arising from the mainstreaming of social media at a time when federal rules carry the threat of steep fines for violating patient privacy. The study, sponsored by tech security firm Imprivata, shows that clinicians waste an average of 46 minutes per day waiting for patient information. The main reasons: reliance on inefficient pagers, no Wi-Fi access, deficient e-mail and bans on use of personally owned devices.
EHR Transition May Be Financially Risky for Hospitals
Adoption of expensive electronic health record systems may hurt a hospital's bottom line, despite promises that the new systems will increase efficiencies and lower costs. Yet another hospital is reporting that the high cost of implementing a new EHR is having a negative effect, with Henry Ford Health System reporting its investment in Epic being a major factor in a 15 percent decrease in net income—from $62.9 million in 2011 to $53.1 million in 2012.
Stanford Team's Text Mining Approach Extracts Useful Information From Clinicians' Notes
Stanford University researchers have developed a method of extracting useful information from unstructured clinical notes in electronic health records. The approach uses ontologies such as the National Library of Medicine's Unified Medical Language System to annotate medical concepts in the notes so that can be mined and analyzed to obtain useful information for things like drug safety studies, hypothesis testing, profiling off-label drug use, and more. According to Nigam Shah, an assistant professor of medicine and the team's leader, the method provides a way for researchers to exploit what to date has been a largely untapped source of valuable medical data. A detailed description of the approach was published earlier this month in Nature Clinical Pharmacology and Therapeutics.
Broad MRSA Screening in UK Not Cost-Effective
The current methicillin-resistant Staphylococcus aureus (MRSA) screening policy in place at the National Health Service (NHS) in the United Kingdom is not cost effective, new research suggests. The NHS recently switched from a policy of screening only high-risk patients to one of routinely screening most patients admitted to the hospital. After that policy change in December 2010, the NHS commissioned a review of the practice. Researchers used an economic model that incorporated representative national data to determine the effectiveness of widespread screening. The findings from the review suggest the NHS would be better off reverting to the old policy, Sheldon Stone, MD, from the University College London Medical School in the United Kingdom, told Medscape Medical News.
Brain-Controlled Exoskeleton to Debut at 2014 World Cup
The first kick of the 2014 FIFA World Cup may be delivered in Sao Paulo next June by a Brazilian who is paralyzed from the waist down. If all goes according to plan, the teenager will walk onto the field, cock back a foot and swing at the soccer ball, using a mechanical exoskeleton controlled by the teen’s brain.
Motorized metal braces tested on monkeys will support and bend the kicker’s legs. The braces will be stabilized by gyroscopes and powered by a battery carried by the kicker in a backpack. German-made sensors will relay a feeling of pressure when each foot touches the ground. And months of training on a virtual-reality simulator will have prepared the teenager — selected from a pool of 10 candidates — to do all this using a device that translates thoughts into actions.
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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