viernes, 4 de abril de 2014



Healthcare News

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


April 04, 2014

View Previous Issues - Healthcare News Archive


CLIAC Charter Renewed

On March 6th Adobe PDF fileExternal Web Site Icon, the Department of Health and Human Services renewed the charter for the Clinical Laboratory Improvement Advisory Committee (CLIAC) through 2016. This longstanding panel advises the government agencies—the Food and Drug Administration, Centers for Medicare and Medicaid Services and the Centers for Disease Control and Prevention-- responsible for implementing the Clinical Laboratory Improvement Amendments of 1988. The first Chair of CLIAC was former AACC President Morton K. Schwartz, PhD, FACB.​

FDA Panel Unanimously Backs Cologuard Colorectal Cancer Test

An advisory panel of the US Food and Drug Administration (FDA) has unanimously recommended premarket approval for the Cologuard (Exact Sciences Corporation) colorectal cancer (CRC) diagnostic device. The Molecular and Clinical Genetics Panel of the FDA's Medical Devices Committee voted unanimously that the test is safe and effective and that its benefits outweigh its risks. Cologuard is an in vitro diagnostic device that analyzes patients' stool to detect hemoglobin, multiple DNA methylation and mutational markers, and the total amount of human DNA contained in cells shed by CRC or advanced adenoma into the large bowel. The test is intended to be used as an adjunctive screening test to detect colorectal neoplasia-associated DNA markers and the presence of occult hemoglobin in human stool. A positive test result may indicate the presence of CRC or premalignant colorectal neoplasia. The device is not meant to be a replacement for colonoscopy and is intended to be used in conjunction with colonoscopy and other test methods according to recognized screening guidelines.

Updated ACMG Recommendations to Allow Patient Opt Out of Incidental Findings

The American College of Medical Genetics and Genomics is updating its recommendations on the return of incidental findings results to individuals who have had their genomes or exomes sequenced in the clinical setting. In a statement, the ACMG said its new guidelines would make it possible for clinical sequencing patients to opt out of receiving information on alterations not related to the diagnosis at hand. The group reportedly reached the decision based on feedback from its members, including a survey that was discussed at a business meeting held during the annual ACMG conference in Nashville, Tenn.

SGR, ICD-10 Extensions Approved by Senate

The Senate approved a bill Monday evening that prevents steep cuts to Medicare physician payments from going into effect for one year and delays the conversion to ICD-10 diagnostic and procedure codes for at least one year. The Senate voted 64-35 in favor of the Protecting Access to Medicare Act of 2014, which the House approved last Thursday. Assuming the president signs the legislation, it will be the 17th such patch that Congress has enacted since the so-called Medicare sustainable growth-rate formula became law in 1997. 


American Clinical Laboratory Association Supports Senate Passage of Provisions for Clinical Laboratory Fee Schedule in SGR Extension Legislation

The American Clinical Laboratory Association (ACLA) – a not-for-profit association representing the nation's leading national and regional clinical laboratories on key federal and state government reimbursement and regulatory policies – voiced support for provisions in the SGR extension legislation passed by the U.S. Senate that reform the Clinical Laboratory Fee Schedule (CLFS) by providing a more rational process for transitioning to changes in reimbursement.


Stool Test 'Accurate for Diagnosing Bowel Diseases'

UK scientists say they have found a way of diagnosing different types of bowel disease by testing the smells given off by patients' stools. The test analyses the chemical compounds emitted and recognises the profile of different diseases. In a study of 182 stool samples from patients with inflammatory bowel disease and irritable bowel syndrome, the results were 76% accurate. The research team said the test could provide more accurate diagnoses. The University of the West of England study, published in the Journal of Breath Research, used a testing system they built combining a gas chromatograph and a metal oxide sensor to recognise patterns specific to known diseases. These patterns are created by volatile organic compounds emitted from stool samples, which are a good indicator of the conditions in the patient's gastrointestinal tract.


New CJD Tests Validated

Further evidence validating tests for both sporadic or classic Creutzfeldt-Jakob disease (CJD) and variant CJD (vCJD) has been reported in 2 new studies, both published recently in JAMA Neurology. The test for sporadic CJD, based on high cerebrospinal fluid (CSF) levels of the protein total tau (T-tau) and the T-tau/phosphorylated tau (P-tau) ratio, was studied by a group led by Tobias Skillbäck, MD, University of Gothenburg, Sweden. "We certainly believe that a lumbar puncture with sampling of CSF should be part of the routine workup of rapid progressive dementias, and our study demonstrates that assessment of tau levels might be a cheap and simple way to add valuable information to the investigation," Dr. Skillbäck told Medscape Medical News. In a paper published online in JAMA Neurology on February 24, Dr. Skillbäck and colleagues report a study in which T-tau and P-tau values were calculated in 9765 deceased individuals with CSF measures, including 93 with CJD.


Gene Test Predicts Melanoma Metastases

A diagnostic test that uses gene-expression profiles can help establish which primary cutaneous melanoma tumors are likely to metastasize, a new study shows. This could help identify patients who could then be put on a more aggressive screening schedule, and perhaps even be given adjuvant therapies such as immune-modulating agents, said Pedram Gerami, MD, associate professor of dermatology and pathology and director of melanoma research at the Northwestern Skin Cancer Institute in Chicago. Molecular diagnostics have begun to change prognostication in other tumors, and "people in the melanoma field are realizing that the time is right for it here, as well," he said. Dr. Gerami presented the research at the American Academy of Dermatology 72nd Annual Meeting.


New Method Can Diagnose Pancreatic Cancer

Pancreatic cancer is often detected at a late stage, which results in poor prognosis and limited treatment options. Researchers at The Sahlgrenska Academy, University of Gothenburg, have now developed a method which can predict with 97 percent certainty which pancreatic cysts constitute precursors to cancer. With this method, which detects the presence of mucus protein, mucins, in the cystic fluid, the researchers were able to reach the correct diagnosis in 77 of 79 cysts that were examined. 

New DNA Test Offers Miscarriage Clues

New research shows an alternative DNA test offers clinically relevant genetic information to identify why a miscarriage may have occurred years earlier. Researchers were able to identify chromosomal variants and abnormalities in nearly 50 percent of the samples. This first-of-its-kind study was conducted by researchers from Montefiore Medical Center and the Albert Einstein College of Medicine of Yeshiva University. The results were published in the March issue ofReproductive Biology and Endocrinology. The technique used in this study, called rescue karyotyping, allows physicians to obtain important genetic information from tissue that had not been tested at the time of the miscarriage. As part of standard hospital protocol, tissue from miscarriages is embedded in paraffin for archival use and the karyotyping test is performed on DNA extracted from this tissue.

Blood Test Shows Promise for Gauging Heart Attack Risk After Chest Pain

Though more study needs to be done, new research suggests that a simple blood test could help predict the heart attack risk of patients experiencing chest pain. The Swedish study found that patients with chest pain who have undetectable levels of a certain chemical signal in their blood called "high-sensitivity cardiac troponin T," plus no sign of reduced blood flow, are at very low risk for heart attack over the next month. The authors of the study, believe the test could help prevent many unnecessary hospital admissions.

Transfusion Strategy Linked to Infection Risk

A restrictive approach to red blood cell transfusion is safer for many patients than a more liberal strategy, researchers reported. In a meta-analysis of 18 randomized trials, the risk of serious nosocomial infection was cut 18% among patients whose doctors ordered a transfusion at a lower hemoglobin level, compared with those whose caregivers used a higher cutoff, according to Mary Rogers, PhD, of the University of Michigan, and colleagues. The risk reduction persisted even when the analysis was restricted to leukocyte-reduced red blood cell transfusions, Rogers and colleagues reported in the April 2 issue of the Journal of the American Medical Association
Widespread use of more restrictive transfusion strategies might help reduce the rate of healthcare-associated infections in hospitals, Post and colleagues argued. The bottom line, according to co-author Neil Blumberg, MD, of the University of Rochester Medical Center in Rochester, N.Y., is that "transfusions have many more risks than we have realized previously."


New Data Show Benefit of Comprehensive Lipid Testing in Determining Risk for Hard Coronary Heart Disease Events

Data presented from two meta-analyses using the Atherotech Vertical Auto Profile (VAP®) Lipid Panel showed the impact high-density lipoprotein (HDL) cholesterol and remnant lipoprotein (RLP) cholesterol have on determining a patient's risk for hard coronary heart disease (CHD) endpoints, such as myocardial infarction or coronary death. Each analysis examined men and women without prevalent CHD enrolled in both the Framingham Offspring and Jackson Heart studies over eight years. In both studies, HDL, the "good" cholesterol in the body and RLP, similar to the "bad" cholesterol in the body (low-density lipoprotein, or LDL) – levels were measured by the VAP® Lipid Panel, the most accurate and comprehensive lipid profile available to assess cardiometabolic risk. While previous study findings have shown the link between HDL and CHD, results from the meta-analyses determined that HDL subfractions, specifically HDL3, were much more predictive in assessing and reducing a patient's risk for CHD, while RLP cholesterol was associated with increasing a patient's risk. 

Inside the Military’s New Office for Cyborgs

Tricorders, Epidemics and Outrunning Disease
On Star Trek, the USS Enterprise’s doctor, Bones, carries around a handheld device called a “tricorder” that can instantly diagnose any disease. DARPA wants it. Rapidly spreading diseases, whether as a result of biological attack or a naturally-occurring epidemic, present a grave and rising national security threat. As previously discussed, a highly-lethal flu pandemic could result in as many as 150 million deaths.
DARPA is looking to create new diagnostic gadgets and software to give soldiers and decision-makers “a rapid and specific diagnosis of infection so we can actually understand the spread of disease, something we don’t have visibility into right now.” The ability to diagnose infections on site, perhaps with a single, handheld device, and then report the results immediately and globally could allow researchers to quickly identify the unique genetic makeup of emerging illnesses. That could help them to “create vaccines that offer immediate protection rather than vaccines that have a few week waiting period before immunity establishes itself. If we can get those capabilities built we can move faster than the disease is spreading,” said Prabhakar. 
The DARPA program is called Autonomous Diagnostics to Enable Prevention and Therapeutics, or ADEPT, and is one example of the effort to conquer biological threats. The agency isn’t alone in moving to build more rapid and deployable diagnostic capabilities. Qualcomm and the X Prize Foundation are sponsoring a $10 million dollar competition to build a handheld diagnostic device. We don’t have to wait for Bones to show before realizing the benefits of the research effort. 
Today, health workers in Saudi Arabia are already using findings from DARPA’s epidemiology-funded research to stay ahead of the Middle East respiratory syndrome coronavirus or MERS-CoV. Prabhakar said it’s a fine and difficult line to walk, laying the research groundwork for the far future while offering new tools as quickly and as rapidly as possible. “We always are aiming for off-scale impact,” she said. “Meantime, we want to make sure we are delivering concrete capabilities.”

FDA Clears Meridian Illumigene Pertussis Test

Meridian Bioscience said that it has received US Food and Drug Administration clearance for its Illumigene Bordetella pertussis molecular diagnostic test. The test amplifies a specific DNA target to detect B. pertussis, providing a definitive result and helping to ensure that patients receive the appropriate antibiotic therapy in a timely manner, the company said.


FDA Clears Focus Diagnostics HSV MDx

Quest Diagnostics announced that its Focus Diagnostics business has received expedited 510(k) clearance from the US Food and Drug Administration and CLIA moderate complexity categorization for its Simplexa HSV 1&2 Direct molecular test on the 3M Integrated Cycler. Quest said the test is the first molecular assay cleared by FDA for the qualitative detection and characterization of herpes simplex virus 1 and HSV 2 in cerebrospinal fluid from patients who are suspected of having HSV central nervous system infection. Using a proprietary chemistry, the test eliminates the need for nucleic acid extraction, reducing costs and the time to result to about an hour, Quest said.


FDA Clears Quidel MDx HSV 1+2 Test

The assay is for use on Quidel's handheld AmpliVue molecular diagnostic device and requires no upfront DNA extraction. The assay is the third AmpliVue assay to be launched by Quidel. The AmpliVue C. difficile assay was cleared by the FDA in late 2012, while the AmpliVue GBS Assay for the molecular detection of Group B Streptococcus was cleared in 2013. 


Venaxis Files for FDA Clearance of Appendicitis Test

Venaxis announced it has submitted a 510(k) application to the US Food and Drug Administration to market its biomarker assay for identifying patients at low risk for appendicitis. APPY1 is a blood-based lateral flow test intended to identify patients who are at low risk for appendicitis and, therefore, may not be candidates for additional imaging tests. It measures three biomarkers: C-reactive protein, white blood cell count, and the MRP8/14 protein.


FDA Study Findings Could Facilitate Development of Safe Artificial Blood

The results of a study by scientists at the US Food and Drug Administration (FDA) could help to simplify the design of a therapy for certain complications of sickle cell anemia, malaria, and other diseases in which red blood cells break apart. The finding also offers important insights into the development of safe and effective hemoglobin-based oxygen carriers (HBOCs) for use in treating individuals suffering significant blood loss due to trauma. The potential therapy would use the blood protein haptoglobin to block the highly destructive chemical reactions triggered by hemoglobin when it escapes red blood cells that have broken apart.


Cedars-Sinai Department of Pathology and Laboratory Medicine Named 2014 Lab of the Year

The Cedars-Sinai Department of Pathology and Laboratory Medicine was named the 2014 Lab of the Year by Medical Laboratory Observer for its commitment to quality patient care — from new technologies to creative opportunities that better serve the local community. The Lab of the Year award is based on a laboratory’s ability to demonstrate contributions to quality patient care. Furthermore, the award recognizes standout leaders in customer service, teamwork, productivity, efficiency, creativity, quality control and lab inspection scores.


Facing the Looming End of Fee-for-Service, Clinical Laboratories and Anatomic Pathology Groups Look for New Business Models

Failing finances at technical pathology laboratories may be the most immediate concern for many pathology group practices 
Many clinical laboratories and anatomic pathology groups now recognize the new reality of the American healthcare system: less reimbursement for laboratory testing. On one hand, the fee-for-service prices for lab tests paid by government and private payers have been aggressively slashed. On the other hand, all payers have become stubbornly resistant to issuing coverage guidelines and setting adequate prices for the flood of new molecular assays and gene tests coming to market.


ACMG Talk Spells Out Details of Medical Exome Project

Researchers from the Children's Hospital of Philadelphia, Harvard University, Massachusetts General Hospital, and Emory University School of Medicine provided additional details about their efforts to annotate and target the exome for clinical applications at the American College of Medical Genetics and Genomics annual meeting.


Genetic Sources of Disease Pinpointed by New Tool

Many diseases have their origins in either the genome or in reversible chemical changes to DNA known as the epigenome. Now, results of a new study from Johns Hopkins scientists show a connection between these two "maps." The findings, reported on the website of the American Journal of Human Genetics, could help disease trackers find patterns in those overlays that could offer clues to the causes of and possible treatments for complex genetic conditions, including many cancers and metabolic disorders. "By showing the connections between genetic variants and epigenetic information, we're providing epidemiologists with a road map," says Andy Feinberg, M.D., M.P.H., a Gilman Scholar, the King Fahd Professor of Medicine and the director of the Center for Epigenetics in the Institute for Basic Biomedical Sciences at the Johns Hopkins University School of Medicine. "Epigenetic tags show how disease-causing genetic variants might affect distant genes that in turn contribute to the disease."


Experts Pioneer Protein Analysis Technique

US scientists are developing mass spectroscopy technology to focus on developing and translating new assays for protein biomarkers related to cancer, diabetes and heart disease. At the Biodesign Institute’s Molecular Biomarkers Laboratory at Arizona State University, US a team of scientists is developing mass spectrometric immunoassay (MSIA) technology - a high-throughput protein quantification technique that also provides detailed protein information including post-translation modifications and genetic variants.


Structure Decoded of Cholesterol Transporter

The word "cholesterol" is directly linked in most people's minds with high-fat foods, worrying blood test results, and cardiovascular diseases. However, despite its bad reputation, cholesterol is essential to our wellbeing: It stabilizes cell membranes and is a raw material for the production of different hormones in the cell's power plants - the mitochondria. Now, for the first time, scientists in Gottingen have solved the high-resolution structure of the molecular transporter TSPO, which introduces cholesterol into mitochondria. This protein also serves as a docking site for diagnostic markers and different drugs, such as Valium. The detailed knowledge of its three-dimensional shape and function opens up new diagnostic and therapeutic perspectives.

Cell Metabolism Discovery Could Spawn Treatments for Cancer or Common Cold

Scientists at UCLA’s Jonsson Comprehensive Cancer Center have published the first study that explains how viruses reprogram the cells they invade to promote their continued growth within an organism. This knowledge could have implications in cancer treatments based on similarities between viruses and cancer cell mechanisms, and even lead to drugs that could inhibit the virus that causes the common cold. Led by Ming Thai, post-doctoral scholar and Heather Christofk, assistant professor of molecular & medical pharmacology, the study was published, April 1, 2014 online ahead of print in the journal Cell Metabolism.


New Gene 'Atlas' Maps Human DNA Activity

Scientists say they've constructed an "atlas" that maps the ways human genes are turned on and off, offering potentially important new insights into health and disease. The new atlas builds on the achievements of the Human Genome Project -- the mapping of all of the approximately 20,500 human genes, first completed in 2003. Speaking at the time of the Human Genome Project's publication, Francis Collins, director of the U.S. National Human Genome Research Institute, called it "a shop manual, with an incredibly detailed blueprint for building every human cell." The new gene-activity map describes those networks that govern genes' activity in major cells and tissues in the human body, according to a team of 250 experts from more than 20 countries.


Self-healing Muscle Grown in the Lab

Scientists have grown living muscle in the lab that not only looks and works like the real thing, but also heals by itself - a significant step in tissue engineering. Ultimately, they hope the lab-grown muscle could be used to repair damage in humans. So far trials have tested this out in mice. The results of this early work are described in the journal Proceedings of the National Academy of Sciences. The Duke University researchers say their success was down to creating the perfect environment for muscle growth - well-developed contractile muscle fibres and a pool of immature stem cells, known as satellite cells that could develop into muscle tissue.

Autism 'Begins Long Before birth'

Scientists say they have new evidence that autism begins in the womb. Patchy changes in the developing brain long before birth may cause symptoms of autism spectrum disorder (ASD), research suggests. The study, in the New England Journal of Medicine, raises hopes that better understanding of the brain may improve the lives of children with autism. It reinforces the need for early identification and treatment, says a University of California team. US scientists analysed post-mortem brain tissue of 22 children with and without autism, all between two and 15 years of age. They used genetic markers to look at how the outermost part of the brain, the cortex, wired up and formed layers. Abnormalities were found in 90% of the children with autism compared with only about 10% of children without.


From Dogs, Answers About Breast Cancer

Mammary cancers in dogs respond to many of the chemotherapy drugs that are used in people, and feature some of the same molecular abnormalities. As in humans, the risk of tumors increases with age, though some breeds, especially smaller dogs, develop the cancer at higher rates than others. Because dogs typically have 10 mammary glands and often develop tumors in several glands at the same time, they present a unique research opportunity, enabling scientists to study lesions that are at different stages of development — from benign to cancerous, and at transitional stages — all in the same animal. “The dog gives us the potential to answer the question: When did something go wrong at the molecular level?” said Dr. Karin Sorenmo, chief of medical oncology at Penn Vet’s Ryan Hospital, who founded the Penn Vet canine mammary tumor program in 2009. “We can also study the benign tumors and ask: What’s different in that one tumor that doesn’t change and become malignant versus another one that does change?”


Allergy-cancer Connection Discovered

Recently published in the Journal of Leukocyte Biology, the study was led by Daniel H. Conrad, Ph.D., member of the Cancer Cell Signaling research program at Massey and professor of microbiology and immunology at the VCU School of Medicine, with substantial contributions from Ph.D. students and co-first authors Rebecca K. Martin and Sheinei J. Saleem. The study demonstrated that histamine, a component of the immune system that responds to allergens and foreign pathogens and is also linked to inflammation, plays a role in protecting tumors from the immune system. By blocking the production of histamine in animal models, the researchers were able to interrupt a process that promotes melanoma growth. "This research is very exciting as it draws a connection between two diseases that aren't commonly linked: allergy and cancer," says Conrad. "However, it's important to realize that this connection is very novel and further research is needed before we know if antihistamines can be used effectively in cancer therapies."


Bones Tell Black Death Story

Ancient skeletons test positive for plague-causing bacteria.
Twenty-five skeletons uncovered in London last year appear to have been part of a larger burial ground for plague victims. DNA sequenced from teeth pulled from the remains confirmed the presence of Yersinia pestis, the bacteria that causes both bubonic and pneumonic plague. Tim Brooks of Public Health England told The Guardian that the Black Death was a pneumonic version of the disease—an airborne infection of the lungs, spread via coughing and sneezing—instead of bubonic—an infection that enters through the skin, infects the lymph system and is spread by rat fleas.


Two British Citizens Catch Tuberculosis From Pet Cat

England's public health agency says two people have caught tuberculosis from a pet cat, the first time the bacterial disease has been documented to spread from cat to human. In a report, Public Health England said it concluded TB samples taken from the cat and from two people in contact with the animal were "indistinguishable" and that the cat was considered to be "the likely source of infection." 


6 Cases of New Tick-Borne Heartland Virus, CDC Reports

The Centers for Disease Control and Prevention (CDC) has advised healthcare providers to consider Heartland virus testing for patients who have otherwise unexplained fever, leukopenia, and thrombocytopenia and who have tested negative for Ehrlichia and Anaplasma infection or have not responded to doxycycline therapy. Heartland is a newly identified phlebovirus believed to be transmitted by the Lone Star tick (Amblyomma americanum). The CDC defines Heartland virus infection as fever (≥100.4°F [≥38.0°C]), leukopenia (white blood cell count, <4500 cells/mm3), and thrombocytopenia (platelet count, <150,000/mm3) without a more likely clinical explanation.


One in 25 Patients Has an Infection Acquired During Hospital Stay, CDC Says

One in 25 patients in U.S. hospitals has an infection acquired as part of his or her care despite modest progress in controlling those pathogens inside medical facilities, the Centers for Disease Control and Prevention reported in its most comprehensive look at a stubborn and lethal health-care problem. The CDC’s 2011 survey of 183 hospitals showed that an estimated 648,000 patients nationwide suffered 721,000 infections, and 75,000 of them died — though it is impossible to tell from the data how many deaths were directly attributable to the acquired infection, said Michael Bell, deputy director of CDC’s division of health care quality promotion. 
Nevertheless, “today and every day, more than 200 Americans with healthcare-associated infections will die during their hospital stay,” CDC Director Tom Frieden said in a news release. The most common infections are pneumonia (22 percent), surgical site infections (22 percent), gastrointestinal infections (17 percent), urinary tract infections (13 percent), and bloodstream infections (10 percent), the agency reported in the study, published in the New England Journal of Medicine.

One-Third of Children Tested in Texas Have Borderline or High Cholesterol

One in three children undergoing routine lipid screening in primary-care pediatric clinics have cholesterol levels considered high or borderline high, according to a new analysis. Regarding LDL-cholesterol levels, 46% of children have borderline-high or elevated levels and 44% have HDL-cholesterol levels considered low or borderline low, report investigators.


Quick Gains After a Smoking Ban

The number of premature births and children’s hospital visits for asthma dropped significantly in parts of the United States, Canada, and Europe barely a year after they enacted smoking bans, researchers reported in The Lancet. The new analysis combined the results of 11 studies encompassing more than 2.5 million births and nearly 250,000 asthma attacks. Experts called it the best evidence to date that legislation creating smoke-free public places and workplaces improves children’s health, even in the womb. The results are “very impressive,” said Dr. Brian Mercer, chairman of obstetrics and gynecology at MetroHealth Medical Center in Cleveland, who noted that half a million American babies are born prematurely each year. “If you could prevent 10 percent, you’d prevent nearly 50,000 premature babies in the U.S. alone each year,” said Dr. Mercer, who was not involved in the study.


10 Medical Tests to Avoid

You may not need these common health exams as often as you think.
The American Board of Internal Medicine Foundation asked more than 50 medical societies — of family doctors, oncologists, cardiologists and other specialties — to identify tests and treatments that are often unnecessary. AARP is a consumer partner with this campaign, called Choosing Wisely.
  1. Nuclear stress tests, and other imaging tests, after heart procedures
  2. Yearly electrocardiogram or exercise stress test
  3. PSA to screen for prostate cancer
  4. PET scan to diagnose Alzheimer's disease
  5. X-ray, CT scan or MRI for lower back pain
  6. Yearly Pap tests
  7. Bone density scan for women before age 65 and men before age 70
  8. Follow-up ultrasounds for small ovarian cysts
  9. Colonoscopy after age 75
  10. Yearly physical

Shorter Shifts Don't Help Medical Residents or Patients

The notorious 24- or even 36-hour shifts that medical residents work in hospitals around the world have been widely criticized for leading to medical errors and poor patient outcomes. This led to a slew of legislation limiting on-call hours. But new research prepared by a trauma surgeon at St. Michael’s Hospital shows that shorter shifts don’t improve patient care and can actually worsen residents’ exam scores


OIG: Most Hospital-based Clinics Overcharge Medicare

Hospitals erroneously bill Medicare millions of dollars a year because they incorrectly classify the patients they treat, according to a report issued by the U.S. Department of Health and Human Services' Office of the Inspector General. Hospitals wrongly classify many patients as "new" as opposed to "returning" or "established," the OIG report said. Medicare pays clinics a higher rate when it treats patients for the first time. While the overpayments themselves were fairly nominal, averaging $21.47, the OIG expressed concern that the error-prone bills are so common. And the error rate is extraordinarily high: of the 110 bills for hospital-based clinic visits surveyed, only two were correctly submitted, according to the OIG. 


Guidance Aims for Safer Use of Lab Data in EHRs

A wide-ranging set of recommended health information technology safety practices recently issued by the Department of Health and Human Services is likely to accentuate the essential role that pathologists and laboratory leaders play in minimizing the adverse consequences of health IT. The guidance comes in response to rising concern over how the move from paper to electronic systems is leading to instances of IT-related patient harm. A November 2011 Institute of Medicine report, “Health IT and Patient Safety: Building Safer Systems for Better Care,” called on the federal government to develop a system to monitor these IT hazards and work to prevent them. 
The SAF ER guides represent one part of the ONC’s broader response, detailed in its July 2013 “Health IT Patient Safety Action and Surveillance Plan.” The SAFER guides are designed to inspire productive, multidisciplinary, interdepartmental collaborations on how to reduce IT- related hazards, says Hardeep Singh, MD, MPH, one of three experts who developed the checklists under contract from the ONC. Many of the SAFER guide recommendations are aimed at using computing power to help prevent ordering physicians from overlooking results, Dr. Singh says. 
Then there are the cases where seemingly simple formatting issues lead to big problems, says Megan E. Sawchuk, MT (ASCP), a health scientist in the Centers for Disease Control and Prevention’s Division of Laboratory Program, Standards, and Services. Sawchuk and her colleagues on the LabHIT Team reviewed the SAFER guides before they were released for use.

HHS Plans for Health IT Exchange Vague, Says GAO

The Health and Human Services Department's strategy for advancing health information exchange focuses too much on general principals and not enough on deliverables, says the Government Accountability Office. The strategy, which the department issued in August 2013, lacks specific, prioritized actions has no milestones and deadlines, finds GAO in a March 24 report. Determining specific actions and setting milestones is critical to helping Centers for Medicare and Medicaid Services and Office of the National Coordinator for Health Information Technology prioritize program actions, say auditors.


Southeast Asia is Polio-free, World Health Organization Rules

The World Health Organization declared Southeast Asia polio-free, marking a global health milestone for India, where the disease accounted for nearly half of all worldwide cases just five years ago. The announcement comes after an independent commission of public health experts determined that the 11-nation region, as defined by the WHO, has not had a confirmed polio case for the last three years.
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