DLPSS|HEALTHCARE NEWS|May 08, 2014
Healthcare News
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
May 08, 2014
News Highlights
CMS Releases Final Rule Allowing for Alternatives Sanctions for PT Referral
Middle East Respiratory Syndrome Coronavirus (MERS-CoV): The Bottom Line for Clinicians
FDA Pushes for Higher Standards on Blood Glucose Meters
Are Pap Smears on the Way Out?
75% of Docs Think Peers Order Unnecessary Tests and Procedures
Old-Fashioned Microscopy Outperforms Automation for Urine Analysis
New Study Shows Routine Blood Glucose Measurements Can Accurately Estimate Hemoglobin A1c in Diabetes
More STD Screening on Horizon for Women?
Alere Starts Urgent Recall of Some Blood Clot Test Strips
New Blood 'Recharges old brain', Mouse Study Suggests
New Virus Related To Smallpox Is Found In Republic Of Georgia
Physician Anxieties Linger as CMS Sets Oct. 1, 2015 Conversion Date for ICD-10
EHR Certification Criteria Under Fire
View Previous Issues - Healthcare News Archive
CMS Releases Final Rule Allowing for Alternatives Sanctions for PT Referral
On April 30, the Centers for Medicare and Medicaid Services (CMS) issued a final rule providing the agency with greater flexibility over its handling of cases involving intentional proficiency testing (PT) referral. The new rule provides the agency with discretion with regard to substituting intermediate sanctions in lieu of the 2-year prohibition on the owner and operator when a CLIA certificate is revoked due to intentional PT referral, and to consider imposing alternative sanctions in lieu of revocation as well.
Source: http://www.ascp.org/
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Middle East Respiratory Syndrome Coronavirus (MERS-CoV): The Bottom Line for Clinicians
MERS-CoV was first reported in Saudi Arabia in September 2012. In a press release issued May 2, 2014, the Centers for Disease Control and Prevention (CDC) identified 401 confirmed cases of MERS-CoV infection in 12 countries, with all reported cases originating in the Arabian Peninsula. Most patients developed severe acute respiratory illness, with fever, cough, and shortness of breath, and 93 patients have died. The case fatality rate in symptomatic patients is 30%.
On May 2, 2014, the first confirmed case of MERS-CoV was reported in the United States. For clinicians practicing in the United States who may have questions, here is the latest guidance, directly from the CDC and the WHO, on MERS-CoV. (Be sure to check the links provided for the most recent information, because this guidance may change rapidly.)http://www.cdc.gov/coronavirus/mers/guidelines-clinical-specimens.html
Source: http://www.medscape.com/
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FDA Pushes for Higher Standards on Blood Glucose Meters
Agency Outlines Separate Tracks for Lay and Professional Use Devices
For the first time, FDA is proposing two separate standards for lay-use blood glucose meters and for those used in the hospital. The latter has been under the most scrutiny by laboratorians, many of whom feel that FDA has overreached. The draft guidance for professional-use meters would require manufacturers to demonstrate that 99% of all values are within ±10% of the reference method for glucose concentrations >70 mg/dL. The current FDA standard is 95% of results within ±20%.
Source: http://www.aacc.org/
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Lucrative Biopsies Spur Fight by Pathologists
For most people, a biopsy is a fast and simple procedure — a sliver or patch of skin or a few drops of fluid are extracted in a doctor’s office and sent to a laboratory for examination. It’s also potentially lifesaving. Biopsies such as Pap smears and the analysis of polyps, tumors and skin anomalies are crucial in detecting certain cancers. But how much a biopsy costs and who pays for it can be complex. For example, a skin biopsy may cost $40 from a discount lab, but a dermatologist may mark up the price and bill the patient two, three or four times the lab rate.
Source: http://www.stltoday.com/
CAP Publishes 2014 Laboratory Accreditation Program Checklists
The College of American Pathologists (CAP) Laboratory Accreditation Program has released the 2014 edition of checklists that are used in the accreditation inspection process to help laboratories meet Centers for Medicare and Medicaid Services (CMS) requirements. The CAP accredits more than 7,600 medical laboratories in 50 countries. CAP inspection teams use the checklists as a guide to assess a laboratory’s overall management and operation. In the 2014 edition, the CAP made modifications to all of its 21 checklists. The greatest number of changes was made in Laboratory General, Anatomic Pathology, Clinical Biochemical Genetics, and Point-of-Care Testing
Source: http://www.mlo-online.com/
Pre-Analytical Errors: Their Impact and How to Minimize Them
The clinical laboratory plays an increasingly important role in the patient-centered approach to the delivery of healthcare services. Physicians rely on accurate laboratory test results for proper disease diagnosis and for guiding therapy. Clinical laboratory errors directly lead to increased healthcare costs and decreased patient satisfaction. Pre-analytical errors damage an institution’s reputation, diminish confidence in healthcare services, and contribute to a significant increase in the total operating costs, both for the hospital and laboratory. More than one-fourth of all pre-analytical errors are estimated to result in unnecessary investigation or inappropriate patient care, thus resulting in additional financial burden on healthcare system. Healthcare economists have developed a model to quantify hospital costs related to laboratory error and inefficiencies due to poor blood specimen quality
Source: http://www.mlo-online.com/
Are Pap Smears on the Way Out?
Women who want to be screened for cervical cancer have just received a new option — and a new quandary. The venerable Pap smear, which has been the only screening tool to look for cancer in asymptomatic women for many decades, now has a rival, a genetic test that looks for the viruses implicated in causing cervical cancer. HPV testing has some advantages over Pap tests. The Roche study showed that it was better able to detect precancerous lesions and a better predictor of whether a woman who tested negative would remain free of lesions for the next three years. The HPV test is also more objective than Pap tests, which rely on the judgment of health professionals viewing slides under a microscope. However, a coalition of 17 consumer, women’s and health groups opposed the approval on grounds that the new test had not been adequately tested, will create confusion and might lead to expensive, invasive, potentially harmful follow-up procedures. The HPV test can cost twice as much as a $40 Pap smear.
Source: http://www.nytimes.com/
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75% of Docs Think Peers Order Unnecessary Tests and Procedures
Asked to rank the top reasons they themselves had ordered extraneous tests or procedures, 52 percent said malpractice concerns, 36 percent said they had ordered them just to be extra-cautious, 30 percent said to get more information to reassure themselves, 28 percent had patients who insisted on the unnecessary procedure, 13 percent wanted to leave the final decision up to their patients, and 5 percent were motivated by the fee-for-service system.
Source: http://www.fiercehealthcare.com/
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Old-Fashioned Microscopy Outperforms Automation for Urine Analysis
The human eye still beats automation when it comes to analyzing urine samples for signs of kidney damage, new research presented at the National Kidney Foundation's 2014 Spring Clinical Meetings shows. An automated urine analysis system missed signs of kidney damage that were identified by a person looking through a microscope at the sample, Dr. Natasha Sharda of the University of Arizona and her colleagues found. Dr. Sharda and her team investigated how well each approach was able to identify granular and muddy brown casts, tiny tube-like structures made of protein secreted by the kidney. Casts in the setting of kidney damage can help identify the underlying problem such as inflammation or infection, Dr. Sharda explained, and counting them and identifying their characteristics and composition can provide important diagnostic and prognostic information.
Source: http://www.medicalnewstoday.com/
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New Study Shows Routine Blood Glucose Measurements Can Accurately Estimate Hemoglobin A1c in Diabetes
Hemoglobin A1c is the standard measurement for assessing glycemic control over time in people with diabetes. Blood levels of A1c are typically measured every few months in a laboratory, but now researchers have developed a data-based model that accurately estimates A1c using self-monitored blood glucose (SMBG) readings, as described in Diabetes Technology & Therapeutics (DTT), a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The authors propose that estimation of real-time A1c could increase individuals' motivation to improve diabetes control.
Source: http://www.medicalnewstoday.com/
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Suicide Biomarkers Getting Closer to the Clinic
Predicting suicidal behavior is coming closer to the clinic as neuroimaging and genetic studies begin to identify structural and functional brain correlates of suicidal behavior that could help identify those most at risk, a comprehensive literature review suggests. "We still don't know why some people take their own lives when confronted with difficult life situations while others who experience the same problems don't even think about suicide," Kees van Heeringen, PhD, Ghent University, Belgium, told Medscape Medical News.
Source: http://www.medscape.com/
Dipstick Test Effective Initial Screen for UTI in Infants
A dipstick test alone may be the best initial screen to test for urinary tract infections (UTIs) in febrile infants, the authors of a study published online April 28 in Pediatrics conclude. Previous studies have demonstrated that dipstick tests work well for children aged 2 years and older. Unlike microscopic analysis, they require neither special training nor a certified laboratory. Moreover, some studies have questioned the added benefit of microscopic analysis, but those studies included few infants.
Source: http://www.medscape.com/
More STD Screening on Horizon for Women?
A federal task force is poised to advise doctors to regularly screen all sexually active American women and girls up to age 24 for the sexually transmitted diseases chlamydia and gonorrhea, which often don't have outward symptoms. The influential group of experts also appears ready to recommend screening for older women at risk of the diseases and provide intensive counseling to people of all ages at extra risk of STDs. The U.S. Preventive Services Task Force hasn't made final decisions about the recommendations it will put forward to the nation's physicians. But the draft guidelines released represent a significant expansion of routine screening for STDs.
Source: http://consumer.healthday.com/
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MIT Researchers Detect Cancer From Urine Specimens by Combining Synthetic Biomarkers With Paper-based Diagnostics
There is now a technology that combines synthetic biomarkers with a paper-based urine test that can detect colorectal cancer and thrombosis in just a few minutes. Medical laboratory tests incorporating this diagnostic technology would be accurate, cheap, and simple enough to perform in developing countries. The new technique uses exogenous agents injected into the patient. These agents bind with tumor proteins. A paper strip test then easily detects the synthetic biomarkers in the patient’s urine. The molecular detection system brings a number of existing technologies together in a new way, reported a story published at gizmodo.com. The result is a new method of cancer signal amplification.
Source: http://www.darkdaily.com/
Alere Starts Urgent Recall of Some Blood Clot Test Strips
Alere Inc said it initiated a voluntary recall of certain blood clot test strips in the United States following reports of nine serious adverse events that included bleeding related to the death of three patients. The test strip, PN 99008G2, measures how long it takes blood to clot in patients taking blood thinner warfarin and is used with Alere's INRatio2 PT/INR monitor. The health diagnostics and services company said the adverse events were due to significantly different test results between the strip and the local laboratory plasma test.
Source: http://www.reuters.com/
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BioMerieux's GI Panel Cleared by FDA
The 22-target panel is for diagnosing infectious diarrhea and includes bacteria, viruses, and parasites in one test. According to BioMérieux, the test is the most comprehensive gastrointestinal panel to be cleared by FDA and contains several pathogens that have received FDA clearance for the first time. The panel runs on the FilmArray system, a closed system that integrates sample preparation, amplification, and detection, and is performed directly from stool in Cary Blair transport media. It takes two minutes to set up and about one hour to produce results, BioMérieux said.
Source: http://www.genomeweb.com/
CLSI Releases New Hematology Standards on RBC Diagnostic and Lupus Anticoagulant Testing
The Clinical and Laboratory Standards Institute (CLSI) has published an updated version of H52-A2—Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second Edition. This standard addresses the diagnostic red blood cell (RBC) assays performed as fluorescence-based assays on a flow cytometry platform, including testing procedures for fetomaternal hemorrhage detection, paroxysmal nocturnal hematuria screening, membrane defect anemia testing for hereditary spherocytosis, and nucleated RBC counting. Points of validation and quality control and caveats of interpretation are also discussed.
Source: http://www.mlo-online.com/
Despite Childhood Obesity Epidemic, Few Kids Tested for Cholesterol
Even though rising obesity rates are contributing to higher cholesterol levels among young Americans, less than 4 percent of U.S. children had their cholesterol levels checked between 1995 and 2010, new research shows. According to a team led by Dr. Samuel Vinci of Boston Children's Hospital, abnormal blood cholesterol reading are thought to occur in roughly a fifth of American children and adolescents. The concern is that -- if left untreated -- problematic cholesterol levels among youth could translate into heart disease in adulthood.
Source: http://consumer.healthday.com/
Vitamin D Deficiency May be Linked to Aggressive Prostate Cancer
Vitamin D deficiency was an indicator of aggressive prostate cancer and spread of the disease in European-American and African-American men who underwent their first prostate biopsy after abnormal prostate-specific antigen (PSA) and/or digital rectal examination (DRE) test results, according to a study published in Clinical Cancer Research.
Source: http://www.mlo-online.com/
Scientists Make Bone Marrow-on-a-chip
The latest organ-on-a-chip from Harvard's Wyss Institute for Biologically Inspired Engineering reproduces the structure, functions and cellular make-up of bone marrow, a complex tissue that until now could only be studied intact in living animals, Institute researchers report in Nature Methods. The device, dubbed "bone marrow-on-a-chip," gives scientists a much-needed new tool to test the effects of new drugs and toxic agents on whole bone marrow.
Source: http://www.laboratoryequipment.com/
Immune Cells Outsmart Bacteria by Dying
A new study led by scientists at the Univ. of Pennsylvania School of Veterinary Medicine has painted a clearer picture of the delicate arms race between the human immune system and a pathogen that seeks to infect and kill human cells. The research explores the strategies by which the bacterial pathogen Yersinia, responsible for causing plague and gastrointestinal infections, tries to outsmart immune cell responses and looks at the tactics used by the immune system to fight back. The senior author of the paper, which appears online in PNAS, is Igor Brodsky, an assistant professor in the Department of Pathobiology at Penn Vet.
Source: http://www.laboratoryequipment.com/
Harvard Neuroscientists Have Made a Discovery That Turns 160 Years of Neuroanatomy on Its Head
Myelin, the electrical insulating material long known to be essential for the fast transmission of impulses along the axons of nerve cells, is not as ubiquitous as thought, according to a new work lead by Professor Paola Arlotta of the Harvard Stem Cell Institute (HSCI) and the University's Department of Stem Cell and Regenerative Biology, in collaboration with Professor Jeff Lichtman, of Harvard's Department of Molecular and Cellular Biology. [The] new research shows that despite myelin essential roles in the brain, "some of the most evolved, most complex neurons of the nervous system have less myelin than older, more ancestral ones" Arlotta, co-director of the HSCI neuroscience program, says. What this means, Arlotta says, is that the higher in the cerebral cortex one looks - the closer to the top of the brain, which is its most evolved region - the less myelin one finds. Not only that, but "neurons in this part of the brain display a brand new way of positioning myelin along their axons that has not been previously seen. They have 'intermittent myelin' with long axon tracts that lack myelin interspersed among myelin-rich segments.
Source: http://www.medicalnewstoday.com/
Healthy Blood Cells of 115-Year-Old Woman Show Hundreds of Mutations
In 2005, a 115-year old woman died and became the oldest person ever to donate her body to science. Now, researchers who analyzed the healthy blood cells in her body say they have identified over 400 genetic mutations, suggesting such lesions are mostly harmless in our bodies over a lifetime. The researchers, led by Dr. Henne Holstege of VU University Medical Center in the Netherlands, publish their findings in the journal Genome Research. Dr. Holstege says as a result of this finding, they "speculate that most hematopoietic stem cells may have died from 'stem cell exhaustion,' reaching the upper limit of stem cell divisions." However, she adds that future studies need to investigate whether stem cell exhaustion is a likely cause of death at very old ages.
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