A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
November 8, 2012
Sequestration Would Leave CDC Short-handed in an Outbreak
Resources needed to battle a public health emergency such as the current meningitis outbreak that has spread to 16 states would take a devastating blow under the across-the-board federal budget cuts set for January, according to public health officials. "Everything's at stake," said Amanda Jezek, government relations director for the Infectious Diseases Society of America. Budget cuts mean shrinking staffs, and that means fewer people to track pathogens, interview patients, test cultures, and update the public. That will add time and difficulty to containing outbreaks and fighting disease, Jezek said.
Although numbers of jobs have not been specified, significant staff cuts would certainly come with sequestration, the indiscriminate budget axe set to strike government agencies, including the Centers for Disease Control and Prevention (CDC), which has been leading the meningitis response. Dr. Benjamin and Jezek say that to see what happens when resources are reduced at the state and local level, look to Washington State's struggle to respond to its pertussis outbreak. According to CDC data, Washington, which declared a pertussis epidemic in April, has nearly 9 times the number of cases this year than it did at the same time last year: 4348 vs. 524. Forty-one new cases were reported just between October 13 and 17. "Their ability to respond has been greatly diminished because of funding cuts," Dr. Benjamin said.
Cranking Up Biosecurity
Recently, the Centers for Disease Control and Prevention (CDC) made the decision to list the SARS virus as a select agent, along with recently discovered haemorrhagic-fever viruses, Lujo and Chapare. This classification, which classifies pathogens or toxins as having the “potential to pose a severe threat to public health and safety,” will require US labs currently holding these viruses but not equipped to qualify as biosafety-level-4 (BSL-4) labs to upgrade their biosecurity measures or get rid of their stocks, Nature reported.
While the moves aim to ensure the safety of the lab workers and the US public, many scientists worry that they will interfere with research. “The threat of criminal prosecution and severe penalties [associated with sharing the high-security viruses between labs] will have a chilling effect on the kinds of collaborative efforts that have characterized SARS work up until now,” Michael Buchmeier, deputy director of the Pacific Southwest Center of Excellence for Biodefense and Emerging Infectious Diseases at the University of California, Irvine, told Nature. About 38 labs around the country will be affected by the new rules.
U.S. Regulator Needs New Authority over Compounding Pharmacies: Report
The U.S. Food and Drug Administration's power to regulate compounded drugs similar to those linked to a deadly meningitis outbreak is legally nonbinding and lacks the authority of stringent standards imposed on drug manufacturers, according to a congressional report. The report, compiled by the staff of U.S. Representative Edward Markey, a Massachusetts Democrat, drew an immediate response from FDA Commissioner Margaret Hamburg, who said the agency is committed to working with Congress and others to garner "the authority we need to help prevent tragedies like this from happening again."
"Over the years, there has been substantial debate within Congress about the appropriate amount of FDA oversight and regulation of compounding pharmacies. But unfortunately, there has been a lack of consensus and many challenges from industry," Hamburg said in a statement emailed to Reuters.
Investigation Faults Handling of Medicare Patient Data Breaches
CMS is not complying with notification requirements and needs to upgrade its database of compromised identities, an OIG report finds. The Centers for Medicare & Medicaid Services has measures to protect physicians from the liabilities that the theft of their Medicare identification numbers could create. But it offers few remedies to Medicare beneficiaries whose identifications have been compromised, according to a report by the Dept. of Health and Human Services’ Office of the Inspector General.
Do HIPAA Rules Apply to Family?
Ms. P's mother had Parkinson disease, was taking numerous medications and was prone to falls. Ms. P's older sister, who lived with her, had Down syndrome. Ms. P would periodically look up her mother's and sister's health records on the hospital computer to get information or to access their treatment plans. She didn't see anything wrong with this — after all, it was her own family. “It doesn't matter if they are family or not. You still [don’t] didn't have the right to look at the records.
HIPAA is taken very seriously, and numerous jobs have been lost based on violations of the rule. A hospital or medical practice cannot afford to have violations, as the federal government strictly enforces HIPAA. It is essential to remember that the privacy of a patient — whether it is someone you know or not — is of paramount importance. Also, pay attention to the policies of your employer. Had Ms. P considered the training she'd had, or the agreement she had signed, she might have realized the dire consequences of looking at unauthorized medical records. Always err on the side of caution.
E.J. Noble Hospital in Gouverneur reopened after the state Department of Health determined its laboratory can perform limited testing. The 37-bed hospital had been closed since the end of September, when the Department of Health shut down its clinical laboratory. Service deficiencies made the lab a risk to patient health and safety, the department said in a news release. But the laboratory has made “significant progress to correct the deficiencies,” according to the Department of Health. It will allow the lab to perform a pared-down list of tests.
At this point, we can propose a working definition of quality control as the concept evolved. Quality control is a means of assuring that laboratory test results are reliable and accurate, by using some known material or method that checks the steps in the test process, and will detect significant errors in the process. The concept is clear to the bench tech. QC is checking all phases of operation of the analyzer: the dilutions, reagents, microprocessors, sample probes, and others.
As medical laboratory scientists, quality control is part of our job, and most of the time, it works and makes sense. But are there QC practices that we perform in the lab that are ineffectual or whose purpose is unclear? Are we performing “empty QC” that satisfies the inspections but doesn’t increase our confidence in the outcome of the test? If so, how did these practices come about, and why does the laboratory industry continue to put up with them?
Doctors’ Mistakes in Genetic Test Orders Is Warning Signal to Pathologists and Clinical Laboratories
Almost one-third of medical laboratory test orders for complex gene tests contained mistakes in handling by ordering clinicians. This finding comes from a study by ARUP Laboratories, Inc. The finding is an early warning flag for pathologists and clinical laboratory professionals that a gap exists between the availability of genetic tests and clinician knowledge of how and when to use them and how to interpret the results.
HIV Screening Not Offered by Urban Hospital Residents
More than 9 of 10 eligible patients admitted to a major hospital in New York City were not offered HIV screening even though state law requires that it be offered. A major barrier to screening appears to be the admitting resident physicians. Marelle Yehuda, MD, a third-year internal medicine resident at Lenox Hill Hospital, New York, New York, reported her medical record review and survey results during a poster session at ID Week 2012.
In September 2010, New York State amended its public health law to require that all patients aged 13 to 64 years be offered HIV screening in primary care, emergency department, and inpatient settings. More than 80% of medical residents were aware of the mandate, but only 9% (8 of 87) of patients admitted in the index survey month were offered HIV screening.
Carlos Del Rio, MD, professor and chair of the Department of Global Health and co-director of the Center for AIDS Research at Emory University in Atlanta, Georgia, said, "I think both [studies] tell us the big gap is between policy guidelines and actual practice. We change polices, we change guidelines, but practice doesn't change."
New Test to Improve HIV Diagnosis in Poor Countries
Scientists have come up with a test for the virus that causes AIDS that is ten times more sensitive and a fraction of the cost of existing methods, offering the promise of better diagnosis and treatment in the developing world.
The test uses nanotechnology to give a result that can be seen with the naked eye by turning a sample red or blue, according to research from scientists at Imperial College in London published in the journal Nature Nanotechnology.
"Our approach affords for improved sensitivity, does not require sophisticated instrumentation and it is ten times cheaper," Molly Stevens, who led the research, told Reuters.
Using a gene-expression test along with bronchoscopy increased the accuracy of a lung cancer diagnosis in patients with suspicious lesions on imaging, the test's developer reported. The test, called BronchoGen, boosted the negative predictive value of bronchoscopic examination from 59% to 87% in a small pilot trial, said Duncan Whitney, PhD, of Allegro Diagnostics in Maynard, Mass., which is developing the test and funded the study.
Whitney, speaking at a late-breaking abstract session during the American College of Chest Physicians annual meeting in Atlanta, indicated that the results would pave the way for more extensive evaluations as well as improvements in the test technology to make it more clinically practical.
Biomarker Discovery Offers Hope for Lung Cancer Blood Test
Blood levels of a variant form of the nuclear matrix protein Ciz1 are significantly higher in individuals with early- and late-stage lung cancer than in lung cancer-free individuals, researchers report.
When a threshold set at the mean of noncancer variant Ciz1 levels was used, the presence of the variant protein discriminated lung cancer patients from cancer-free individuals with an accuracy of 98%, irrespective of cancer stage. Furthermore, the mean signal intensity of detected Ciz1 variant levels was significantly higher among individuals with lung cancer (n=119) than among those with no or nonmalignant lung disease (n=51), at respective intensities of 95.8 and 14.1.
Biomarkers in Cerebrospinal Fluid Can Identify Patients with Alzheimer´s Disease
In an article published in the Journal of the American Medical Association, Swedish researchers claim that an analysis of specific biomarkers in a cerebrospinal fluid sample can differentiate patients with Alzheimer’s disease from those with other types of dementia. The method, which is being studied by researchers at Sahlgrenska Academy, University of Gothenburg, may eventually permit earlier detection of Alzheimer’s disease.
“Previous studies have shown that Alzheimer’s disease is associated with biochemical changes in specific proteins of the brain,” says researcher Annika Öhrfelt. “This study has found that the inclusion of a new protein can differentiate patients with Alzheimer’s disease from those with Lewy body dementia, Parkinson’s disease dementia, and other types of dementia.
Cheap and Simple Microfluidic Lab-on-a-Chip Detects Analytes
Brigham Young University researchers have developed a simple new way of detecting tiny concentrations (down to a nanogram – one billionth of a gram) of a given chemical without the use of any complicate and expensive equipment.
They created narrow channels within glass slides that are lined with receptors for the chemical to be quantified. When a sample drop is placed at one end of a channel, it is drawn in by capillary action. As the target molecules are captured by the receptors, the channel gradually becomes constricted. The distance that the liquid manages to travel is inversely proportional to the quantity of the target molecule in the sample.
Source: Source: http://medgadget.com/
Transdermal Patch Continuously Monitors Blood Chemistry—Without Needles and Clinical Pathology Laboratory Testing
New blood chemistry monitoring device could replace some traditional laboratory testing.
There’s a new technology that makes it possible to continuously monitor an individual’s blood chemistry and wirelessly transmit the data. This technology uses a transdermal patch and is a different approach to clinical diagnostics with the potential to supplant some traditional medical laboratory testing. This transdermal patch was developed by Sano Intelligence, one of San Francisco-based Rock Health’s startups for 2012. These developments were reported in a story published by Co.EXIST.
Transdermal Patch Could Monitor Components of Basic Metabolic Panel
“Sano is building a small, wearable sensor that can capture and transmit blood chemistry data continuously to virtually any device,” stated Sano on its website. The company will test the patch in a pilot study in collaboration with a research-focused medical institution. The device could be ready to launch sometime next year, according to Co.EXIST writer, Ariel Schwartz.
Each Patient Has a Unique Breath 'Fingerprint' That Doctors Could Use to Diagnose
It's the ultimate noninvasive medical test: A growing number of health problems can be diagnosed by analyzing a patient's breath alone. The concept goes back to Hippocrates, who wrote a treatise on breath aroma and disease around 400 B.C. For centuries afterward, doctors noticed that patients with liver and kidney disorders had distinctive smells to their breath.
Now, scientists are identifying thousands of chemical compounds that create those telltale odors. Tools called mass spectrometers can detect them in quantities as minute as parts per trillion, the equivalent of finding a single ping-pong ball in a thousand baseball fields filled with ping-pong balls.
Analyzing Your Kids' DNA
Time magazine has been "exploring the promise and pitfalls of sequencing children's genomes" in a five-part series on "Kids and DNA" this week.
In the first article, Time reporter Bonnie Rochman asks how much information parents would want to learn from a whole-genome sequencing test of their child or unborn child. An NIH-funded study led by Ian Krantz and Nancy Spinner at the Children's Hospital of Philadelphia is trying to find out just that, but even the husband-and-wife principal investigators "are divided on what they'd want to know about their own children and about each other."
Additionally, a privately funded study at the Inova Translational Medicine Institute plans to enroll 2,500 families, offering to sequence parents and their newborn children and asking them what results they want to obtain.
NHGRI to Fund Genomics Courses for Biomedical Community
The National Human Genome Research Institute plans to fund development of short courses that will spread information about genomics methods and techniques and will update researchers on many of the ethical, legal, and social implications (ELSI) of new genomics advances.
Under a new funding opportunity, NHGRI will provide up to $50,000 to support classes less than two weeks in length that will be hosted by academic institutions or research institutes. These courses should be targeted to individuals at the doctoral level and beyond and should be led by established investigators or scholars who are actively working in the areas that the courses will cover. NHGRI will provide up to three years of support to fund these genomics education efforts.
Quest May Bring 1,200 Jobs to Marlborough.
Quest Diagnostics Media Relations Manager Wendy Bost said the company has signed a "non-binding letter of intent to lease property in the city for the possible future development" of the lab and administrative offices. Quest Diagnostics plans to invest about $78 million to renovate the space. The company expects to have 957 full-time employees at the site, and would pledge to add 246 additional jobs over the 15-year life of the tax deal.
Verinata Sues Ariosa, LabCorp for Patent Infringement
Verinata Health announced it is suing Ariosa Diagnostics and Laboratory Corporation of America for patent infringement. Verinata filed its lawsuit in the US District Court for the Northern District of California, alleging Ariosa and LabCorp infringe US Patent No. 8,296,076 entitled, "Noninvasive diagnosis of fetal aneuploidy by sequencing." The patent was issued to Stanford University on Oct. 23, 2012, and is licensed exclusively to Verinata.
Blood is frequently ordered before surgery, even for procedures that rarely require blood transfusion, researchers reported at Anesthesiology 2012: American Society of Anesthesiologists 2012 Annual Meeting. Using data acquired through an anesthesia information management system (AIMS), investigators from The Johns Hopkins School of Medicine, Baltimore, Maryland, found that clinicians ordered type and screen (T&S) or type and cross-match (T&C) for more than one third of surgical patients during the 2-year study period. However, just 0.23% of patients required transfusion.
"Data from AIMS can be used to create updated, institution-specific maximum blood order schedules [MBOS]," said James Rothschild, MD, who described his group’s efforts to optimize blood ordering by first comparing preoperative blood orders to the actual need for transfusion at his institution. "We propose that optimizing blood ordering will lead to cost savings, improved operating room efficiency, and increased patient safety," he said.
Human Blood Types Have Deep Evolutionary Roots
Chimps, gibbons and other primates are not just humans’ evolutionary cousins; a new analysis suggests they are also our blood brothers. The A, B and O blood types in people evolved at least 20 million years ago in a common ancestor of humans and other primates, new research suggests.
The analysis deepens a mystery surrounding the evolutionary history of the ABO blood system, and should prompt further research into why the different blood groups have persisted over time, Laure Ségurel of the University of Chicago and colleagues report online October 22 in the Proceedings of the National Academy of Sciences.
Smart Bandages Could Staunch Blood Flow From Wounds
Glass fiber is an excellent material for slowing down blood flow, but it can’t be used to dress wounds because glass particles can get into the body and cause damage. So Gajjar’s team tried to replicate the properties of glass fibers in materials that people can wear every day. They found that a chemical called tetraethyl orthosilicate (TEOS) has properties similar to those of the surface of glass, but with none of the damaging side effects.
In an experiment the team coated a variety of fabrics—such as cotton, polyester, and nylon—with TEOS and mixed the fabric samples together with human blood plasma. They measured the time it took for each sample to begin forming thrombin, a blood-clotting agent. The treated fabrics reduced the time it took for the plasma to begin clotting by 25 to 30 percent, and the treated cotton worked the best. "It was not as close to glass as we would like, but the time to clotting can be significantly reduced by using chemical treatments," Gajjar says. And that means the treated fabrics could potentially close up wounds faster and save more lives than traditional bandages.
Scientists Move Closer to a Lasting Flu Vaccine
As this year’s flu season gathers steam, doctors and pharmacists have a fresh stock of vaccines to offer their patients. The vaccines usually provide strong protection against the virus, but only for a while. Vaccines for other diseases typically work for years or decades. With the flu, though, next fall it will be time to get another dose. In the history of vaccinology, it’s the only one we update year to year,” said Gary J. Nabel, the director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases.
That has been the case ever since the flu vaccine was introduced in the 1950s. But a flurry of recent studies on the virus has brought some hope for a change. Dr. Nabel and other flu experts foresee a time when seasonal flu shots are a thing of the past, replaced by long-lasting vaccines. “That’s the goal: two shots when you’re young, and then boosters later in life. That’s where we’d like to go,” Dr. Nabel said. He predicted that scientists would reach that goal before long — “in our lifetime, for sure, unless you’re 90 years old,” he said.
A Weak Spot in H.I.V.’s Armor Raises Hope for a Vaccine
The search for a vaccine against AIDS has been long and fruitless — mostly because the virus mutates so fast. As is well known, flu vaccines have to be reformulated every year because influenza viruses mutate so steadily. But the human immunodeficiency virus, which causes AIDS, mutates as much in a single day as flu virus does in a year, presenting scientists with an almost insurmountable challenge.
Recently, South African researchers announced that they had found a vulnerable spot on the virus’s outer shell that might present a good vaccine target, and that they had also learned, for the first time, at what stage of an infection it develops. They found only two women whose virus had the vulnerability — and it wasn’t the same virus that first infected them, but a mutant that developed a few months later. The research, published by Nature Medicine on Oct. 21, was praised as “very interesting” by several AIDS experts.
Scientists have replaced bits of defective DNA in a human egg with the equivalent DNA from a healthy egg, a technique that could prevent women from passing on several rare and potentially deadly disorders to their children. In a laboratory test, many of the eggs containing the transplanted DNA got properly fertilized, and many went on to yield healthy human embryos. The latest study is an extension of a 2009 experiment performed by the same U.S. team on monkeys. The monkey experiment was taken one step further and led to live births. In the latest study, published in Nature, the scientists report that those animals, now three years old, are alive and well.
Three-Parent Fertility Method Could Remove Gene Defects
A controversial gene therapy technique has produced human embryos free of defective maternal genes responsible for rare, debilitating diseases. Biologists in Oregon report they've produced early-stage human embryos with genes from three parents, a new method that someday may keep babies from inheriting rare diseases carried by maternal genes.
The gene transplant researchers led by Masahito Tachibana of the Oregon Health & Science University in Beaverton, produced early-stage human embryos that contained healthy versions of "mitochondrial" DNA, which only comes from a mother. Defects in those genes can cause diseases involving muscle weakness, brain abnormalities and other ailments that occur in 1,000 to 4,000 births every year nationwide.
Answers and Questions
Whole-exome and whole-genome sequencing raise a number of possibilities, but also questions for use in the clinic. While neither technique is yet a routine diagnostic tool, Jeantine Lunshof from VU University writes in Personalized Medicine that emergencies can speed the introduction of new techniques into medical care, but that there are, a number of ethical issue to consider, particularly when the patient is a child. Lunshof recalls the example of a boy whose exome was sequenced by a team at the Medical College of Wisconsin to pin down the source of the boy's bowel disease. In that case, the Wisconsin team noted a number of ethical issues, not the least of which learning about "'off-target' results" from the reams of data generated and what to tell patients or their parents.
More Proof That Fecal Transplant Banishes C. Diff
Evidence continues to pile up for fecal transplantation in C. difficile infection, with another single-center study reporting high "cure" rates in infected patients. A total of 46 out of 49 patients treated with intestinal microbiota transplant, or IMT, were quickly rid of their symptoms and had no adverse effects, Mayur Ramesh, MD, of Henry Ford Hospital in Detroit, and colleagues reported at IDWeek 2012. Evidence continues to accumulate regarding the benefit of fecal transplanation in C. difficile infection, with another single-center study reporting high "cure" rates in infected patients. All patients tolerated the procedure well with no adverse events.
Immunity Finding to Help Stem Spread of Viruses
Scientists have discovered how mosquitoes develop viral immunity - a significant finding with the potential to halt the spread of crippling mosquito-borne viruses, such as dengue and West Nile.Researchers from CSIRO's Australian Animal Health Laboratory in Geelong showed that a protein called vago is released by infected mosquito cells. It warns other cells to fight the invading virus, effectively giving the insect's immune system a heads up. ''It's front-line defence,'' said virologist Peter Walker, who worked on the research over 18 months with colleague Prasad Paradkar.
To get a full characterization of fire ant venom components, Palma and his colleagues combined both a two-dimensional gel electrophoresis approach and a high-performance liquid chromatography MS/MS approach. This allowed them to identify 46 proteins, some of which were not previously known to be in fire ant venom. The proteins also play a number of roles. "Some of these proteins are related to envenomating ... but half of the material, 50 percent of the proteins, present other functions," Palma says.
Smoke-free Workplace Laws Linked to Fewer Heart Attacks, Study Finds
A decline in the number of cases of myocardial infarction, or heart attack, in one Minnesota county appears linked to smoke-free workplace laws in that area, research published in the Archives of Internal Medicine finds. Researchers at the Mayo Clinic in Rochester, Minn. looked at the number of heart attacks among residents of Olmsted County, Minn. that occurred 18 months before and after implementation of laws banning smoking in restaurants in 2002, and the 18 months before and after those laws were extended to include all workplaces, including bars, in 2007. They found that the incidence of heart attack declined by a third (33 percent) from the start of the study to the end (i.e., from the 18 months before the first laws to the 18 months after the second laws went into effect). They also found a smaller decline (17 percent) in cases of sudden cardiac death between the two periods.
Women Who Quit Smoking Do Live Longer
Life expectancy was dramatically improved among participants in Great Britain's Million Women Study who quit smoking compared with continuous smokers, confirming the previously uncertain benefits of smoking cessation in women, researchers said.
Although women who stopped smoking around age 50 remained at significantly higher risk of all-cause mortality compared with never-smokers. "Even cessation at about 50 years of age avoids at least two-thirds of the continuing smoker's excess mortality in later middle age," the researchers wrote online in The Lancet.
CMS Circulates Final 2014 MU Clinical Quality Measures
The Centers for Medicare & Medicaid Services (CMS) has published the final 2014 clinical quality measures (CQMs) for eligible professionals and eligible hospitals seeking to attest for meaningful use. Beginning in 2014, the reporting of clinical quality measures will change for all providers. Electronic health record (EHR) technology that has been certified to the 2014 standards and capabilities will contain new CQM criteria. Eligible professionals (EPs), eligible hospitals and critical access hospitals will report using their respective new 2014 criteria – regardless of whether they're taking part in participating in Stage 1 or Stage 2 meaningful use.
In addition to these quality measures, CMS has published the specifications for electronic reporting and access to the related data elements and value sets.
CDC Girding to Open its Cloud to Public Health
Tom Savel, MD, is that rare breed of physician who contends his real goal in life is to be a technologist. Savel, like any IT guy worth his weight in geek, thinks big – which is exactly how what started as a software-testing sandbox five years ago is now on the cusp of being a quiver of cloud computing capabilities offered to health entities.Within the Centers for Disease Control and Prevention (CDC), Savel is the director of the Informatics Research and Development Activity (IRDA), under the Public Health Surveillance and Informatics Program Office.
The CDC is about to open IRDA's cloud to federal, state, and local health departments.
Executives surveyed by Beacon Partners, a health-care management consulting firm based in Weymouth, Mass., expressed dissatisfaction with hospitals’ efforts to measure the return on investment of IT clinical systems, according to a summary of the survey's results. More than 300 health-care executives responded to the survey.
Only 36 percent of respondents were satisfied with how performance-measure data were used to assess the value EMRs brought to their organizations, according to the findings. Measurements usually related to quality management, not ROI, they said. Slightly more than half of the executives said they would have preferred performance measures that were developed earlier in the EMR implementation process.
3 Health IT Must-haves for Natural Disaster Preparedness
Responding to disasters is something every healthcare institution needs to be ready for. From hurricanes to snowstorms to wildfires, having a plan in place and technology to back it up is critical to an effective response.
During these times of crisis many simple things, such as contacting relatives of patients or ordering crucial supplies can become major headaches if an adequate plan is not arranged beforehand. As many healthcare centers employ a higher than average concentration of IT equipment, there are certain ways they can leverage them to cope with disasters- and things they must do to safeguard their technology as well.
- On-site safety
- Off-site data
Understanding Workflow Key to EHR Success
In any extended policy discussion, topics have a tendency of rising to the top of the attention list, then slipping back down. But some topics, particularly those which at first don’t seem too important, keep rearing their heads. Take “workflow” as it relates to the development and implementation of EHRs. It’s never been as sexy as meaningful use or interoperability, but it persists, and in persisting it makes clear how important understanding office workflow is to the entire effort to transition the healthcare sector to EHRs.
Feds Probe Link Between Non-medical Opioid Injections, Blood Disorder in 12 Tenn. Patients
Federal authorities say they are working with Tennessee officials to investigate why at least 12 patients in that state who injected the pain reliever Opana ER for non-medical reasons since February have a rare blood disorder.
The Centers for Disease Control and Prevention issued the health advisory regarding the pain reliever, an extended-release form of oxymorphone. The CDC is working with the Food and Drug Administration and the Tennessee Department of Health.
States Seek Help Making Health Exchange Rules
Limited guidance meant to give states room to develop individualized health exchanges may be hampering their ability to meet a Nov. 16 deadline to let Washington know if they will create their own.
As the federal government tries to leave the states with the freedom to set up individualized local health exchanges, state officials say they've received so little guidance that they're afraid they'll have to make changes as more regulations come out after the presidential election. "CMS is walking a very fine line with providing guidance while trying not to be too prescriptive," said Kevin Counihan, CEO of Connecticut's Insurance Exchange. "We can either say, 'I don't know enough to move,' or, 'We're going to do the best we can with what we have.' If we do something wrong, we can beg the government for forgiveness later."
The American Medical Association and the Medical Assn. of Georgia are stepping into a legal battle over whether Georgia can impose payment timelines on the processing of claims through self-funded health plans.
America’s Health Insurance Plans, a national trade association representing insurers, sued Georgia Insurance Commissioner Ralph T. Hudgens in August over the state’s Insurance Delivery Enhancement Act of 2011. The law, scheduled to go into effect in January 2013, requires companies that provide third-party administrative services to pay medical claims in a timely manner. AHIP, which wants a judge to block the law’s enactment, says the state has no authority to regulate self-funded health plans.
Americans' Understanding of ACA is 'Staggeringly Low', Harvard Professor Says
The Affordable Care Act has polarized Republicans and Democrats despite the fact that many voters cannot explain the healthcare reform legislation to any significant degree, said Robert Blendon, ScD, professor of health policy and political analysis at the Harvard School of Public Health during a speech to the Massachusetts Medical Society on Oct. 18. “The level of understanding of what the ACA does is staggeringly low, even for people who love it,” he said. “Most Americans do not understand the context of the legislative policy for how it will affect their lives.”
Wal-Mart Gives Major Boost to Domestic Medical Tourism Movement
The retailer joins the ranks of companies sending employees to hospitals far from home in the name of less expensive and better care.
A small but growing number of U.S. corporations are offering their insured employees the option of undergoing certain procedures at highly ranked health systems across America at almost no out-of-pocket cost to them — travel included. The companies believe sending heart and spine patients elsewhere would result in improved care for patients and lower costs for employers. Although companies are just getting started in pushing what is often called domestic medical tourism, analysts say it’s something doctors should keep an eye on. Physicians may find patients bypassing them on the way to health systems elsewhere. Others may be handling pre- and post-care for procedures performed hundreds or thousands of miles away.
Dr. April Pettit, Tennessee Doctor, Credited With Cracking Meningitis Outbreak Mystery
A Tennessee doctor who ordered "extra tests" on the spinal fluid of a patient is credited by colleagues with unlocking the mystery of a devastating fungal meningitis outbreak and prompting a national alert that may have saved lives. Dr. April Pettit, an infectious diseases specialist at Vanderbilt University, could not figure out last month why a patient in his 50s was not responding to standard antibiotic treatments for meningitis, her colleagues at the school told Reuters.
During her research and discussions with the man's family, she discovered that he had received an epidural steroid injection at St. Thomas Outpatient Neurosurgical Center in Nashville. She then asked the Vanderbilt laboratory to check the man's spinal fluid for a rare form of meningitis, caused by a fungus rather than bacteria or a virus, which cannot be fought with conventional medications. A spinal tap showed the presence of Aspergillus fumigatus. The patient, who was started on the anti-fungal drug voriconazole, became the first documented case of a fungal meningitis outbreak linked to potentially tainted steroids.
Meningitis: Death Toll at 28
Three more people -- two in Michigan and one in Tennessee -- have died of fungal meningitis, the CDC reported Tuesday. The tally in the outbreak, linked to spinal injections of a contaminated steroid, now stands at 356 cases of the disease -- 28 of them fatal -- in 19 states.
The CDC said its labs have confirmed that 52 patients with fungal meningitis have Exserohilum rostratum in clinical specimens. Two other patients have a lab-confirmed fungal infection, one with Aspergillus fumigatus and one with Cladosporium.
J&K Government Sets up Mobile lab to Screen Dengue Victims
Jammu and Kashmir government has set up a mobile clinical laboratory to check and screen the people coming to Jammu and Kashmir for dengue infection at Lakhanpur inter-state Toll Plaza, gate way to the state.
"We have set up a mobile testing lab to check and screen the people coming infected with dengue at Lakhanpur inter-state Toll Plaza in Kathua district", Chief Medical Officer (CMO) Kathua, Ajay Khajuria told reporters.