A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
September 5, 2013
- HHS Offers FAQs on Individualized Quality Control Plan (IQCP)
- Total Analytic Error
- The Quest to Define Normal Values in Children
- Negative Troponin and Copeptin Tests Rule out Acute Coronary Syndrome
- Children Given Antibiotics for UTIs Without Urine Testing
- NIH Program Explores the use of Genomic Sequencing in Newborn Healthcare
- Food-Parasite Probe Hindered by Budget Deficiencies
- Berwick: Get Rid of Medicare 3-day Payment Rule
- American Medical News Ceases Publication After 55-year Run
- Miniature 'Human Brain' Grown in Lab
- Physicians Struggle to Take Full Advantage of EHRs
View Previous Issues - Healthcare News Archive
HHS Offers FAQs on Individualized Quality Control Plan (IQCP)
CMS is implementing a new quality control option based on risk management (IQCP). IQCP will provide laboratories with flexibility in customizing quality control (QC) policies and procedures based on the test systems in use and the unique aspects of each laboratory. A transition and education period will begin Jan. 1, 2014 and will conclude Jan. 1, 2016. Following is a list of Frequently Asked Questions provided by HHS.
- What is IQCP?
- What are the three parts of an IQCP? What is required in an IQCP?
- Is IQCP intended to reduce the amount of quality control in laboratories?
- Are CLIA QC regulations changing to accommodate IQCP? What about other CLIA quality system requirements?
- Will accrediting organizations (AO) and exempt states (ES) be required to accept the use of the IQCP option?
- Are all specialties and subspecialties eligible for IQCP?
- What is the timeline for Implementing IQCP?
- Will there be an Education and Transition period?
- What happens to Equivalent Quality Control (EQC)? And Why?
- Will any test systems currently eligible for EQC be "grandfathered"?
Berwick: Get Rid of Medicare 3-day Payment Rule The simmering controversy over observation care might reach a boiling point now that Don Berwick, M.D., former administrator for the Centers for Medicare & Medicaid Services, has jumped into the fray. When Berwick, who is now an official candidate for Massachusetts governor, led Medicare from July 2010 to December 2011, he considered eliminating Medicare's three-day payment rule for hospitals, a position he reinforced during a recent interview with The Boston Globe.
We all know that children are not just small adults. Many changes occur in children as they grow and develop that can affect how a drug works. In fact, some drugs that work in adults may not work at all in children. There may be different safety concerns compared to when they are used by adults, or they may need to be given in a different dose. That’s why products that are used in children must be studied in children.
Congress enacted two laws that will increase the study of drugs in children: The Best Pharmaceuticals for Children Act (BPCA) provides an incentive for drug companies to conduct FDA-requested pediatric studies by granting an additional six months of marketing exclusivity. The Pediatric Research Equity Act (PREA) requires drug companies to study their products in children under certain circumstances. When pediatric studies are required, they must be conducted with the same drug and for the same use for which they were approved in adults.
3D-Printed Medical Devices Spark FDA Evaluation
The FDA currently treats 3D-printed devices the same way it treats conventionally made medical devices, an FDA spokeswoman said. "We evaluate all devices, including any that utilize 3D printing technology, for safety and effectiveness, and appropriate benefit and risk determination, regardless of the manufacturing technologies used," spokeswoman Susan Laine told LiveScience in an email. She added, "In some cases, we may require manufacturers to provide us with additional data, based on the complexity of the device." In order for a new device to receive FDA approval, its creators must either prove the device is equivalent to one already marketed for the same use, or the device must undergo the process of attaining premarket approval. Anyone, not just medical device companies, can submit a device for approval. But because 3D-printed products are made using a different manufacturing method than traditional medical devices use, they could require additional or different forms of testing. Two FDA laboratories are looking into ways 3D printing could affect the way medical devices are manufactured in the future.
State Bill to Boost Use of Nurse Practitioners Goes Nowhere
An effort to ease a shortage of primary-care doctors in some California communities by letting nurse practitioners operate more independently has flat-lined in the Legislature after a fierce lobbying battle. A bill by Sen. Ed Hernandez (D-West Covina) would have allowed nurse practitioners, who have more training than registered nurses, to practice without the direct supervision of a physician. The proposal failed in a committee, under fire from the California Medical Assn., the powerful lobbying arm for the state's physicians.
Food-Parasite Probe Hindered by Budget Deficiencies
Federal authorities are struggling to explain why 600 people in 22 states have fallen ill from a foodborne parasite rarely seen in the United States. But some officials are ready to finger one culprit that has hindered their investigation: the sequester. The Centers for Disease Control and Prevention has had to slash $285 million at a time when food and health experts say disease detection needs more funding as these type of food outbreak cases become more complex and widespread.
Taylor Farms, which is the largest supplier of leafy greens in the U.S., said its operation has undergone more than 1,800 tests, and every single one of which has come back negative for the parasite. After voluntarily suspending operations for two weeks, the company has resumed operations and instated regular testing for Cyclospora. Meanwhile, CDC officials are circling around another possible explanation. “We’re coming to the conclusion that this may be two separate outbreaks,” said Dr. Robert Tauxe, deputy director of the CDC’s Division of Foodborne, Waterborne and Environmental Diseases. “It’s very difficult to come up with any explanation that connects the two.” Significantly hindering the CDC is that it does not have the technology it needs to conduct the “genetic fingerprinting” that would tell investigators which illnesses are linked to a common source, Tauxe said.
Confusion, unhappiness, and many unresolved issues remain about the way government and private payers are handling claims for molecular diagnostic tests covered by the 114 new CPT codes. Dust is settling from the fiasco triggered by the Medicare program’s failure to be ready on January 1, 2013, to settle molecular diagnostic test claims filed under the 114 new Tier 1 and Tier 2 molecular CPT codes. The damage is not just limited to Medicare test claims, but also involves private health plans that were waiting to let the Medicare program set precedents on coverage and prices for the new molecular test codes.
Revision for Laboratory Procedure Review
The Joint Commission recently approved a revision to Quality System Assessment for Nonwaived Testing (QSA) Standard QSA.05.01.01, Element of Performance (EP) 4, addressing how frequently policies and procedures of blood transfusion services are reviewed for the laboratory accreditation program. Effective immediately, the revised requirement allows the blood transfusion service director or technical supervisor to review blood transfusion policies and procedures every two years instead of annually.
American Medical News Ceases Publication After 55-year Run
Unsustainable financial losses forced the move despite the newspaper's editorial quality, the AMA's senior management says. The Association's other news operations will be enhanced. A dramatic drop in medical-publishing revenues has resulted in the closure of American Medical News, effective with this final edition of the newspaper. Published for more than five decades, AMNews was hit hard by industrywide trends. The newspaper's revenue fell by two-thirds during the last decade, said Thomas J. Easley, senior vice president and publisher of periodic publications at the American Medical Association.
For those of us who practice cytology, the glass microscope slide is a purely utilitarian object; a necessarily transparent, hard surface upon which cells of diagnostic interest can be permanently mounted for present visualization and future archiving. Although we may acknowledge a certain aesthetic appeal to the well-prepared, well-stained cytology specimen (or perhaps even the "artistry" of the occasional exuberant pleomorphic adenoma); The Art and Science of Cytopathology notwithstanding, most of us don't exactly consider glass microscope slides to be true objets d'art. However, a few weeks ago I discovered, to my great surprise, that there was a time in the not-so-distant past when the glass microscope slide was a medium of veritable artistic expression. It was an artist's canvas of sorts and actually a popular medium of entertainment for the middle class.
Total Analytic Error Today clinical laboratories have come under increased pressure to implement quality systems and new risk management guidelines for quality control in order to ensure timely and accurate delivery of test results. However, one issue that is often overlooked in these efforts is the actual quality goal or requirement for a laboratory test. In simple terms, the question that laboratory professionals should be asking is: how good does a test need to be? As laboratories attempt to answer this basic question, other questions quickly become evident—how should the laboratory define the quality goal? how should the laboratory validate the analytical methods to satisfy the goal? and what is the best way for the laboratory to assure those goals are achieved in routine testing? An effective system for managing analytical quality can be developed based on the concept of total analytic error (TAE), a useful metric both to assess laboratory assay quality and to set quality goals for assays. Other tools, such as Sigma metrics, method decision charts, Sigma statistical quality control (SQC) selection graphs, and charts of operating specifications are also useful.
The Quest to Define Normal Values in Children The first analyses of blood spot samples from the National Institutes of Health’s National Children’s Study are now underway in the laboratories of two members of AACC’s Pediatric Reference Range Committee (PRRC), Patti Jones, PhD, and Dennis Dietzen, PhD. Using tandem mass spectrometry, the researchers are conducting studies of the precious samples collected from healthy newborns to define age-specific reference ranges for steroid hormones and amino acids that impact children’s development. “It took a decade for the National Children’s Study to get to where it is now,” said Michael Bennett, PhD, FRCPath, referring to the efforts that are aimed at enlisting a diverse population of 100,000 healthy children at birth and following them for 21 years.
The diagnostic performance of the latest screening enzyme-linked immunosorbent assay (ELISA) for syphilis has been compared with the currently used treponemal tests. The etiological agent of syphilis, Treponema pallidum, cannot be cultured and there is no single optimal alternative test. Serological testing is the most frequently used approach in laboratory diagnosis of the disease. Scientists at Sekisui Virotech (Rüsselsheim, Germany) compared their Treponema pallidum Screen ELISA with standard tests. The authors concluded that the Virotech Screen ELISA demonstrated good diagnostic sensitivity and specificity when evaluated as a screening test for syphilis among various patient populations, including samples with increased rates of false positive nontreponemal test results.
Negative Troponin and Copeptin Tests Rule Out Acute Coronary Syndrome
In the present study, known as the Biomarkers in Cardiology 8 (BIC-8) trial, researchers tested the emergency-department biomarker risk-stratification strategy in 902 patients at low to intermediate risk of ACS. Suspected acute coronary syndrome (ACS) patients with a negative troponin test and a negative copeptin test (Brahms, Thermo Scientific) can be safely discharged from the hospital without further testing, according to the results of a new study presented at the European Society of Cardiology (ESC) 2013 Congress. in Amsterdam, the Netherlands.
"The clinical need for instant rule-out of acute myocardial infarction and early discharge is based on the fact that we have an overcrowding of emergency facilities," said lead investigator Dr Martin Möckel (Charité-Universitätsmedizin Berlin, Germany) during a press conference announcing the results. "Ten percent of patients in the emergency department present with chest pain, but only 10% of those patients are having a real acute myocardial infarction. We do an extensive workup on patients who do not need specific cardiovascular care."
Children Given Antibiotics for UTIs Without Urine Testing
New research suggests that pediatricians may often prescribe antibiotics for urinary tract infections (UTIs) without first obtaining urine tests, despite guidelines that suggest otherwise. The American Academy of Pediatrics currently suggest that providers obtain a urinalysis or a urine culture for children aged 2 to 24 months before prescribing antibiotics for a UTI, and current guidelines from the National Institute for Health and Clinical Excellence recommend urine testing in children aged 3 to 36 months. Testing is recommended for infants and young children, as they cannot communicate and often present with symptoms associated with multiple conditions. Older children can communicate their symptoms more effectively; therefore, there are no guidelines for testing in children older than 3 years.
A research team at the University of Gothenburg in Sweden is using Quanterix's Single Molecule Array, or Simoa, platform to identify blood biomarkers related to brain injury. "Tau is one of the markers for neurons. If you have a concussion, it may alter the expression of tau, and that will show up in the blood," Henrik Zetterberg, head of the department of psychiatry and neurochemistry at the university, told BioArray News. By using Quanterix's arrays to profile protein-level changes in hockey players one hour after concussion and then every morning after that up to six days, Zetterberg's team aims to be able to develop a test or tests that can predict if a concussion will lead to a more severe brain injury. Such prognostic assays could "change the course of treatment" for affected athletes, as well as reduce the use of healthcare resources, such as CT scans or in-hospital visits, that are currently used to monitor players who have suffered a concussion, Zetterberg said.
Risk Factors Identified at Diagnosis Help Predict Outcomes for Children With Rare Heart Condition
A long-term study of children with a complex heart condition called hypertrophic cardiomyopathy (HCM) found that the risk of death or need for immediate listing for heart transplantation was greatest for those who developed this disease as infants with congestive heart failure and for children who also had selective inborn errors of metabolism, a group of rare genetic disorders in which one or more of the body’s key metabolic processes are disrupted. The findings will be published online in The Lancet to coincide with a presentation at the European Society of Cardiology Congress 2013 meeting in Amsterdam. The National Heart, Lung, and Blood Institute (NHLBI) and the Children’s Cardiomyopathy Foundation supported this research. Hypertrophic cardiomyopathy, a type of pediatric cardiomyopathy (diseases of the heart muscle) with varied causes and outcomes, is characterized by increased thickness (hypertrophy) of the heart wall.
NIH Program Explores the Use of Genomic Sequencing in Newborn Healthcare
“Genomic sequencing has potential to diagnose a vast array of disorders and conditions at the very start of life,” said Alan E. Guttmacher, M.D., director of NICHD. “But the ability to decipher an individual’s genetic code rapidly also brings with it a host of clinical and ethical issues, which is why it is important that this program explores the trio of technical, clinical, and ethical aspects of genomics research in the newborn period.” The awards will fund studies on the potential for genome and exome sequencing to expand and improve newborn health care. Genomic sequencing examines the complete DNA blueprint of the cells, and exome sequencing is a strategy to selectively sequence exons, the short stretches of DNA within our genomes that code for proteins.
The National Institute on Drug Abuse plans to fund new research projects that aim to discover more about the changes that chronic exposure to drugs cause in the brain, including efforts focused on changes at the genetic, molecular, and cellular levels. NIDA also plans to support efforts to understand how pharmacological, behavioral, and other therapeutic interventions affect the brain, and how the brain protects itself from the effects of abused drugs.
Ariosa Inks Mexico Deal for Harmony Test
Ariosa Diagnostics announced that it has inked a partnership with Advance Medical to offer its Harmony Prenatal Test to clinicians in Mexico. The San Jose, Calif.-based firm said that Mexico is now one of 46 countries around the world where the Harmony test is available to healthcare providers. The Harrmony test is based on next-generation sequencing technology and provides a direct analysis of cell-free DNA in blood. According to Ariosa, the test has an accuracy rate above 99 percent for evaluating trisomy 21 risk, with a false positive rate of 0.1 percent.
TB Has Human, not Animal, Origins - Says Study
The origins of human tuberculosis have been traced back to hunter-gatherer groups in Africa 70,000 years ago, an international team of scientists say. The research goes against common belief that TB originated in animals only 10,000 years ago and spread to humans. The work, published in Nature Genetics, outlines the strong relationship between the evolutionary history of both humans and TB. The disease causes more than one million deaths every year.
Mammals Harbour 'at Least 320,000 New Viruses'
There could be at least 320,000 viruses awaiting discovery that are circulating in animals, a study suggests. Researchers say that identifying these viral diseases, especially those that can spread to humans, could help to prevent future pandemics. The team estimates that this could cost more than £4bn ($6bn), but says this is a fraction of the cost of dealing with a major pandemic. The research is published in the journal mBio.
Miniature 'Human Brain' Grown in Lab
Miniature "human brains" have been grown in a lab in a feat scientists hope will transform the understanding of neurological disorders. The pea-sized structures reached the same level of development as in a nine-week-old foetus, but are incapable of thought. The study, published in the journal Nature, has already been used to gain insight into rare diseases. Neuroscientists have described the findings as astounding and fascinating. The human brain is one of the most complicated structures in the universe. Scientists at Institute of Molecular Biotechnology of the Austrian Academy of Sciences have now reproduced some of the earliest stages of the organ's development in the laboratory. They used either embryonic stem cells or adult skin cells to produce the part of an embryo that develops into the brain and spinal cord - the neuroectoderm.
A clue to why memory deteriorates with age has been found by US researchers. Experiments on mice suggested low levels of a protein in the brain may be responsible for memory loss. It is hoped the discovery could lead to treatments to reverse forgetfulness, but it is a big leap from the mouse to a human brain. The study, published in the journal Science Translational Medicine, said age-related memory loss was a separate condition to Alzheimer's disease. The team at Columbia University Medical Centre started by analysing the brains of eight dead people, aged between 22 and 88, who had donated their organ for medical research. They found 17 genes whose activity level differed with age. One contained instructions for making a protein called RbAp48, which became less active with time.
Genomic Differences Discovered in Types of Cervical Cancer
A new study has revealed marked differences in the genomic terrain of the two most common types of cervical cancer, suggesting that patients might benefit from therapies geared to each type's molecular idiosyncrasies. The study, published in the online version of the journal Cancer by researchers at Dana-Farber Cancer Institute and Brigham and Women's Hospital (BWH), is the first to compare the spectrum of cancer-related gene mutations in the two main subtypes of cervical cancer - adenocarcinoma and squamous cell carcinoma. In tests on 80 cervical tumor samples, the investigators found high rates of mutations in two genes: PIK3CA and KRAS. While PIK3CA mutations appeared in both subtypes, KRAS mutations were found only in adenocarcinomas.
New CDC Vital Signs: CDC Finds 200,000 Heart Disease and Stroke Deaths Could Be Prevented
More than 200,000 preventable deaths from heart disease and stroke occurred in the United States in 2010, according to a new Vital Signs report from the Centers for Disease Control and Prevention. More than half of these deaths happened to people younger than 65 years of age, and the overall rate of preventable deaths from heart disease and stroke went down nearly 30 percent between 2001 and 2010, with the declines varying by age. Lack of access to preventive screenings and early treatment for high blood pressure and high cholesterol could explain the differences among age groups.
The Case for Clearing More Arteries During Heart Attacks
An aggressive approach to preventing heart attacks could be the next big thing in the long battle against this leading cause of death. A British study presented in Amsterdam finds that doctors can reduce future heart attacks and cardiac deaths by opening up multiple clogged coronary arteries while they're fixing the artery that's causing a heart attack in progress.
Gene Tweak Boosts Lifespan by 20 Percent in Mice
But NIH study also found more bone loss, greater infection risk in engineered rodents
By suppressing a gene involved in metabolism and energy balance, researchers extended the average lifespan of a group of mice by about 20 percent -- thought to be one of the longest lifespan increases ever observed in mice. This is the equivalent of extending the average human lifespan by 16 years, from 79 to 95 years old, the U.S. National Institutes of Health researchers said. Although the study also revealed that this gene, known as mTOR, does not affect every tissue and organ the same way, the researchers said their findings could help scientists develop new therapies for aging-related diseases -- such as Alzheimer's -- that target specific organs. Scientists note, however, that research conducted in animals often fails to provide similar results in humans.
Sleep May Aid in Brain Repair, Mouse Study Finds
Meanwhile, sleep deprivation appeared to harm brain cells
The reproduction of cells involved in brain repair is boosted during sleep, according to a new study of mice. Researchers from the University of Wisconsin, Madison, found that sleep increases the process by which certain cells, known as oligodendrocytes, form myelin. Myelin is the insulation on nerve cells in the brain and spinal cord that allows electrical impulses to move rapidly from one cell to another. In conducting the study, published in the Sept. 4 issue of the Journal of Neuroscience, the researchers examined the myelin-forming cells of mice that slept, as well as those of mice that were deprived of sleep. Genes that promote the production of this insulation were activated during sleep, the researchers found. Meanwhile, the genes linked to cell death and the cellular stress response were activated among the mice that were forced to stay awake. "These findings hint at how sleep or lack of sleep might repair or damage the brain," Mehdi Tafti, a sleep researcher at the University of Lausanne in Switzerland, who was not involved with this study, said in a journal news release.
Frequent Coffee, Chocolate Consumption Reduced Liver Enzymes in HIV/HCV Coinfected Patients
Patients coinfected with HIV and HCV who reported eating chocolate daily and drinking three or more cups of coffee a day had lower levels of ALT and AST than those who consumed fewer polyphenol-rich foods in a recent study. Researchers evaluated data collected from 990 adult patients coinfected with HCV and HIV enrolled in the ANRS CO13 HEPAVIH prospective cohort study. Patients with cirrhosis had follow-up visits every 6 months, while noncirrhotic participants had annual visits, with liver biochemistry assessed at each visit. Participants also responded to annual self-administered questionnaires regarding sociodemographic status and dietary and drug habits.
Blueberries, not Fruit Juice, Cut Type-2 Diabetes Risk
Eating more fruit, particularly blueberries, apples and grapes, is linked to a reduced risk of developing type-2 diabetes, suggests a study in the British Medical Journal. Blueberries cut the risk by 26% compared with 2% for three servings of any whole fruit - but fruit juice did not appear to have the same effect. The research looked at the diets of more than 187,000 people in the US. But Diabetes UK said the results of the study should be treated with caution.
Hypertension Unrecognized Half the Time
Worldwide, more than half of all patients with hypertension are unaware they have the condition, researchers found. Among a population of patients from 17 countries with hypertension, only 46.5% were aware of their diagnosis, according to Salim Yusuf, MD, DPhil, of Hamilton General Hospital in Hamilton, Ontario, and colleagues. The majority of those who were did know they had high blood pressure received drug treatment for hypertension (87.5%), but only about a third of those had their hypertension under control (32.5% of those receiving drug treatment), they wrote online in the Journal of the American Medical Association.
More Teens Getting Recommended Vaccines
Although more teens are getting recommended vaccines, doctors say rates are still too low. As kids go back to school this week, more of them are fully immunized against infectious diseases, a new study shows. While the number of fully vaccinated kindergarten students has always been high — with more than 90% getting most vaccines — fewer 11- and 12-year-olds get all their recommended shots. A new report from the Centers for Disease Control and Prevention, however, shows progress among this age group.
Life Expectancy Grows for Women Age 50 and Up
Life expectancy for women who live to age 50 is going up around the world, but poor and middle-income countries could easily make greater gains, according to a new World Health Organization report. Heart disease, stroke and cancer kill most women over 50, said Dr. John R. Beard, director of the W.H.O.'s department of aging, so countries should focus on lowering blood pressure with inexpensive drugs and screening for cervical and breast cancer. Those diseases can be prevented or treated, said Dr. Beard, who was also an author of the study, which was published in the Bulletin of the World Health Organization.
Disturbing Thyroid Cancer Rise in Fukushima Minors
Six minors in Fukushima Prefecture who were 18 or younger at the time of the March 2011 nuclear disaster have been diagnosed with thyroid cancer since June. Ten other children are believed to have developed the same form of cancer in that time period. The latest figures released by regional authorities brings the total number of children who have been diagnosed with or suspected of having cancer to 44, up from 28 as of June, the Asahi Shimbun national daily reports. Of the 44, 18 have been diagnosed with thyroid cancer, and 25 others are showing symptoms. Another child suspected of having cancer was later diagnosed with a benign tumor.
Physicians Struggle to Take Full Advantage of EHRs
New findings published in Annals of Internal Medicine show that the number of physicians using basic electronic health records (EHR) increased by 10% in just over 1 year, but that only a small percentage of these physicians use the advanced EHR functions that have the most potential to increase patient care quality while reducing costs. Under the Centers for Medicare and Medicaid Services (CMS) “meaningful use” standards for EHRs, providers meeting specific criteria for using EHRs to report their performance on quality measures are eligible to receive incentive payments from CMS. The authors concluded that additional training, as well as further research on usability, may be needed to help physicians reap the full benefits of EHRs.
Patient engagement and electronic HIE are the game changers of Stage 2 meaningful use requirements, which were designed to further expand the meaningful use of certified EHR technology. For patient engagement, the Centers for Medicare and Medicaid Services added two core objectives – providing patients with online access to health information and providing secure messaging between patient and provider. This white paper highlights results from a study conducted by IDR Medical GmbH that surveyed 1,000 U.S.-based patients regarding their attitude toward patient portal technologies.
Health IT Spending on Pace to top $34.5B
Healthcare IT spending will top $34.5 billion in North America in 2014, according to a new report by research firm Technology Business Research. The Hampton, N.H.-based firm attributes the spending to regulatory mandates' demand for modernization of infrastructure to meet new healthcare guidelines, according to an announcement, and lays out how the money will be spent. "The wide variety of regulatory mandates and changes coming into force in the near term in the U.S. magnifies the pressure on healthcare providers, commercial payers and public sector agencies to maximize the value and ROI of their IT spend to meet these requirements," TBR healthcare analyst Joseph Walent said in the announcement. "Health IT vendors able to recognize the IT spending habits of the market segments, and adjust accordingly, will be best positioned to secure market share."
What Could Make Your Medical Devices Go Haywire?
Computer viruses could potentially make medical devices go haywire, and anything from your intravenous (IV) pumps to ventilators, laboratory analysis equipment, and CT scanners could be affected. Medical devices are currently attracting a great deal of federal scrutiny, all because of a relatively new phenomenon: their vulnerability to malware, hackers, and the other miseries usually associated with computers. Physicians' offices tend to be more vulnerable than hospitals to malware because they have less access to IT expertise, according to W. Reece Hirsch, an attorney specializing in healthcare security breaches in the law firm of Morgan, Lewis & Bockius in San Francisco. "This will become more of a problem as networks become more important," he said.
Fee-for-Service Payment to Phase Out in Five Years? That’s the Recommendation of National Commission on Physician Payment Reform
How quickly will fee-for-service disappear as a primary source of reimbursement for clinical laboratories, pathologists, hospitals, and physicians? If the recommendation of one credible group of physicians has its way, fee-for-service reimbursement could disappear in as little as five years. This recommendation was made by National Commission on Physician Payment Reform as part of a report it issued in May. In its press release, the commission issued a call “for eliminating stand-alone fee-for-service payment by the end of the decade.” The group urges a transition over five years to a blended payment system that will yield better results for both public and private payers, as well as patients.”
Experts Say Rural Healthcare in Crisis
Some states' refusal to expand Medicaid and a recommendation by the Department of Health & Human Services to recertify critical access hospitals are causing concern about rural access to healthcare. According to a health economist, if states refuse to expand Medicaid in accordance with healthcare reform, the rural poor will be hit the hardest, the Minneapolis Star-Tribune reports.
Hospital-Acquired Infections Rack Up $9.8B a Year
Hospital-acquired infections (HAI) cost $9.8 billion per year, with surgical site infections alone accounting for one-third of those costs, followed closely by ventilator-associated pneumonia at 31.6 percent, according to research published in JAMA Internal Medicine.
Healthcare Providers Fall Short in Preventing Spread of Infection, Joint Commission Says
The nation's hospitals, nursing homes and outpatient clinics continue to fall short when it comes to performing necessary—and sometimes very basic—steps to prevent the spread of infection that can cause illness or death, new data from the Joint Commission show. The Joint Commission, which accredits the quality and safety of healthcare operators, released its ranking of standards (PDF) that proved most problematic for healthcare companies in the first six months of 2013. The ranking, organized by type of provider, lists the five standards for which healthcare organizations were most often not in compliance. Nearly half of hospitals, 47%, did not comply with processes to reduce the risk of infections associated with medical equipment, devices and supplies. Among ambulatory care operators, such as outpatient surgery centers, 37% failed to meet the same standard. One out of five long-term care providers and one out of four home care providers did not meet guidelines for hand hygiene.
Dominican Creates New Master Program for Clinical Lab Science
Dominican University of California has launched a new Master of Science in Clinical Laboratory Sciences program, aiming to address the need for training in business and scientific practices for upper-level professionals in biological, medical and pharmaceutical labs, according to those who lead development of the new program. It is currently the only master’s degree program in California that provides a two-year continuing education curriculum tailored for licensed clinical lab professionals, combining aspects of advanced clinical lab work with the business skills associated with managing a medical laboratory, planners said.
Federal Trade Commission Files Complaint Against LabMD of Atlanta for Failing to Protect Consumer's Privacy
The Federal Trade Commission filed a complaint against medical testing laboratory LabMD Inc. alleging that the company failed to reasonably protect the security of consumer’s personal data, including medical information. The complaint alleges that in two separate incidents, LabMD collectively exposed the personal information of approximately 10,000 consumers. The complaint alleges that LabMD billing information for over 9,000 consumers was found on a peer-to-peer (P2P) file-sharing network and then, in 2012, LabMD documents containing sensitive personal information of at least 500 consumers were found in the hands of identity thieves.
Emory University to pay $1.5M for Overbilling Medicare, Medicaid
Atlanta's Emory University has agreed to pay $1.5 million for overbilling Medicare and Medicaid in a violation of the False Claims Act, according to an announcement from the U.S. Department of Justice. Emory, according to the DOJ, billed Medicare and Medicaid for clinical trial research at the university's Winship Cancer Institute, despite the fact that the sponsor of the trials had already agreed to pay those costs. In some cases, the sponsor and the federal healthcare programs both paid for the same services.
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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