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A new level of excellence. A new era of microscopy.
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For more information, call 800-446-5967 or visit olympusamerica.com/VS110 today.
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Focus on Breast Cancer Awareness Month
Breast cancer is the most commonly diagnosed cancer among American women, other than skin cancer, but deaths from breast cancer have dropped more than 2% each year since 1990, according to the report, Breast Cancer Facts & Figures 2009-2010, released by the American Cancer Society. If breast cancer is caught early, the five-year survival rate is 98%, researchers say. Data from 2006 shows the breast cancer death rates have dropped nearly 30%. When this data is translated into the number of women with breast cancer who did not die, some 130,000 lives were saved. Learn more at www.cancer.org.
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ASCP and NCA unite
The American Society for Clinical Pathology (ASCP) Board of Registry (BOR) and the National Credentialing Agency for Laboratory Personnel (NCA), signed an agreement on July 21 forming a single certification agency for medical laboratory professionals. The agency will be called the ASCP Board of Certification (BOC). The agreement is effective on Oct. 23, when the NCA will be dissolved as a corporation. The “ASCP” suffix will be attached to all BOC certifications. Current and active certifications will be transferred to the ASCP BOC; no examination will be required for the transfer. Medical technologists (MT) and clinical laboratory scientists (CLS) will be called medical laboratory scientists (MLS). The designation will be MLS(ASCP). Visit www.ascp.org/bor and www.nca-info.org for more information.

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New Age Labeling for Medical Labs
With 2D barcodes, tons of critical data relating to point-of-care or hospital protocol can be reliably stored in a tiny matrix symbol. If you’re looking for a technically-advanced labeling system for your hospital or laboratory, click here to read about the advantages of 2D bar coding. Contact EIMINC, a leader in laboratory labeling for a free 2D Barcode Demo. |
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Hot Clips on Phlebotomy
Readers often remark that they love to “clip” various items from the print pages of MLO. And because MLO covers a myriad of laboratory-related topics, in this issue we share a new LABline feature: Choice MLO Clippings. Click on the highlighted words to discover various MLO archival properties concerning Phlebotomy.
Phlebotomy has been a popular subject at MLO throughout the years. Whether it is an article about starting an in-house phlebotomy training course or studying how to perform a quality collection, MLO has relied on its resident expert, Dennis J. Ernst, director of the Center for Phlebotomy Education, to steer our course in his area of expertise. From taking the guesswork out of venipunctures (an article on products/technology for locating veins) to his involvement with a coalition for phlebotomy personnel standards dedicated to the certification of phlebotomists, this MLO editorial advisory
board member manages to cover all phlebotomy bases.
Learn a little more about phlebotomy through this series of “hot clips” published from October 2005 through Ernst’s latest article, “Phlebotomy certification legislation: update on three of our 50 states” from our October 2009 issue.
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NEW! Backyard raccoon latrines pose risk to kids
Raccoons establish community sites where they repeatedly deposit fresh feces, which can pose a health risk to children, researchers say. If the animal is infected with a parasite known as Baylisascaris procyonis, its feces can contain about 20,000 eggs per gram, scientists report in the September issue of Emerging Infectious Diseases. The raccoon is the definitive host of B procyonis; but in intermediate hosts, such as humans, it causes baylisascariasis, also known as raccoon roundworm encephalitis. In humans, larvae from ingested eggs do not mature into the adult form of the worm. Instead, the larvae migrate through the body — including the eyes and brain — where they form granulomas that can cause severe and permanent damage. Researchers studied 119 backyards in the suburbs of Chicago. They found raccoon latrines in 51% of the yards, with up to six separate latrines in some yards. Eggs of B procyonis were found in 23% of the sampled latrines. Since the parasite spreads via the fecal-oral route, the danger is to small children who can ingest the eggs if their hands touch their mouth after playing in an infected backyard, which can lead to serious and sometime fatal neurological illness. Learn more at
www.cdc.gov/eid/content/15/9/1530.htm.

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NEW! Scientists discover origin of malaria
The most malignant known form of malaria may have jumped from chimpanzees to humans, according to scientists at the Global Viral Forecasting Initiative. Chimps native to equatorial Africa have been identified as the original source of the parasite that likely moved from them to humans via mosquitoes. An international group of researchers made the discovery, published in the Aug. 3 issue of Proceedings of the National Academy of Sciences, by identifying several new parasites from chimps. The newly discovered parasites show that malaria jumped from animals to humans, much the way HIV, SARS, and swine flu originated. According to the study, genetic analysis shows that the Plasmodium falciparum parasite, which accounts for nearly 85% of all malaria infections in humans, is a mutated form of the parasite found in chimps. The newly discovered parasites not only demonstrate how malaria originated, but represent potentially powerful tools for developing vaccines and treatments. Learn more from the Global Viral Forecasting Initiative at
www.gvfi.org.

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NEW! Pall named a Top Green company
Global filtration, separation, and purification company Pall Corp. has been named one of the greenest companies in America in Newsweek magazine’s Sept. 28 issue. Pall was ranked second in the industrial goods sector and 47th among America's 500 largest companies. Pall adopted aggressive environmental sustainability goals as part of its long-term plan. The company is on track to reduce its global carbon footprint by 10% in each of three categories — energy consumption, carbon emissions, and waste output — by 2010. To read the Newsweek article, visit http://greenrankings.newsweek.com; and to learn about the company's corporate sustainability initiatives, visit www.pall.com/green.

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NEW! Website offers RSV and flu testing information
Luminex has launched a new website, www.xTAGRVP.com, to provide information on respiratory viruses and current diagnostic testing options available. Split into two user-friendly sections — one for patients and one for physicians — the site offers answers to a variety of questions on how to avoid and detect respiratory viruses, including the flu. It also features sections on 2009 Influenza A/H1N1, downloadable case studies, FAQs, and a glossary of respiratory virus-related terms.

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NEW! Keep up on legal issues and regulatory changes
Recently enacted laws and new regulatory requirements are creating new risks for clinical laboratories and anatomic pathology groups. Find out what your lab should do to stay on the right side of the law in the audioconference, “New Legal Issues and Regulatory Changes and Their Potential Impact on Clinical Laboratories and Pathology Groups” Tuesday, Oct. 27, 1 p.m. EDT. Pathologists will be particularly interested in regulatory updates involving recent trends in anatomic pathology. The audioconference will include presentations by a panel of experts, followed by questions and comments from attendees. Learn more and register at
www.darkdaily.com/audio-conferences/new-legal-issues-and-regulatory-changes-and-their-potential-impact-on-clinical-laboratories-and-pathology-groups.

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NEW! FDA OKs Tem-PCR H1N1 test
DIATHERIX Laboratories has been granted emergency use authorization from the U.S. Food and Drug Administration (FDA) its DIATHERIX H1N1-09 Influenza Test. The test utilizes the company’s proprietary molecular technology, known as Target Enriched Multiplex Polymerase Chain Reaction (Tem-PCR), which is used for the detection of the H1N1-09 influenza viral RNA. The test is used on nasopharyngeal swabs, nasal swabs, throat swabs, and nasal aspirates from patients with signs and symptoms of respiratory infection in conjunction with clinical risk factors. Learn more at
www.diatherix.com.

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CDC updates flu test information
The Centers for Disease Control and Prevention (CDC) has issued interim recommendations for clinical use of influenza diagnostic tests during the 2009-2010 influenza season. For information regarding the use of influenza diagnostic tests, including a comparison of available tests, visit www.cdc.gov/h1n1flu/guidance/diagnostic_tests.htm

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50,000+ bulb life in EuroStar II
Log the savings in bulb cost plus have confidence the constant light intensity will not affect reading with the EuroStar II for FITC Microscopy. Enjoy on-demand use with no need to warm it up or cool it down. Its bulb features over 500 times the life of a mercury bulb while not requiring a darkened room. A digital camera accessory is available. The Plus model’s halogen-transmitted light offers brightfield and darkfield, phase contrast or polarization microscopy in addition to the LED for fluorescence.
www.euroimmunus.com | info@euroimmunus.com | 800-913-2022
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Bacterial co-infections common in fatal cases of flu
Many people who have died from 2009 H1N1 influenza in the United States had co-infections with a common bacteria (Streptococcus pneumoniae, or pneumococcus) which likely contributed to their death, according to a report published in the CDC’s Morbidity and Mortality Weekly Report. The CDC report includes an analysis of specimens taken from 77 fatal cases of 2009 H1N1. Bacterial co–infections, including some caused by Streptococcus pneumonia, were noted in about a third of those cases. The entire MMWR can be found at www.cdc.gov/mmwr.

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Free resources for flu season
The CDC has made available a variety of 2009-2010 flu season print materials, such as fact sheets, flyer, brochures, posters, and stickers. This year’s seasonal flu materials include messages to address the 2009 H1N1 flu recommendations. All materials are free for download and can be printed on a standard office printer. Go to www.cdc.gov/flu/freeresources/print.htm.

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Diagnostic tests critical to healthcare reform goals
Amidst ongoing debate in Congress over reforming the nation's healthcare system, a new report from the Lewin Group finds that screening and diagnostic laboratory tests are central to achieving some of the most important goals of healthcare reform. According to the report, tests for conditions such as diabetes, cervical cancer, drug-resistant infections, and metastatic colon cancer are enabling important strides in early detection and diagnosis, as well as in helping physicians select treatments that will work most effectively for patients. The net result is often better health outcomes for patients, as well as greater savings and economic efficiencies for the healthcare system — all key goals of healthcare reform. The report addresses the cost and clinical implications of lab testing by focusing on four areas: Rapid diagnostic tests for hospital-acquired MRSA infections, KRAS genetic testing, HbA1c blood glucose testing, and HPV DNA testing for cervical cancer. The report was
sponsored by the American Clinical Laboratory Association, Results for Life, and AdvaMed. The full report is available at
www.labresultsforlife.org and www.advamed.org.

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Sharps Safety For Subculture Procedures Now Available
A safe alternative for performing subculture procedures. ITL Corporation introduces the Safety SubCulture Unit - a needleless device designed for safely and easily obtaining samples from all positive blood culture bottles.
To learn more about this innovative product, please visit www.itl-limited.com/pr_scu.php. If you would like to request samples Click Here.
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Blood test may prevent overuse of antibiotics
Unnecessary use of antibiotics for respiratory infections might be lowered with a simple blood test, according to a study by Swiss researchers, reports HealthDay News. A new study published in the Sept. 9 issue of the Journal of the American Medical Association found that testing for the chemical procalcitonin (PCT) in patients with infections such as bronchitis and pneumonia reduced rates of antibiotic use and side effects associated with the drugs. Higher levels of procalcitonin are found in patients with bacterial infection than in those with a virus. This Swiss team randomly assigned almost 1,359 patients with lower respiratory-tract infections to receive antibiotics based on results of a PCT test or based on standard guidelines. Patients in the PCT group were on antibiotics for an average of 5.7 days, compared with 8.7 days in the untested group.

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Blood test for TB often inexact in children
A new type of blood test for tuberculosis (TB) has limitations for use in children — especially very young children and those with abnormal immune function — reports a study in the August issue of The Pediatric Infectious Disease Journal. London researchers analyzed the results of interferon-gamma release assays (IGRA) in 237 children with suspected or possible TB. IGRA tests are increasingly being used in place of conventional skin tests for diagnosing latent (present but inactive) TB infection or active TB disease. The study found that 35% of the children had “indeterminate” results from IGRA tests, meaning the results were unclear as to whether or not they had TB infection or disease. Many of the children had abnormal immune function; for this group, the rate of indeterminate results reached 66%. Indeterminate results were also more likely for younger children. The IGRA test missed one-fourth of children who later developed confirmed tuberculosis. Learn more at
www.pidj.com

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Vaccine protects nearly one-third from HIV in Thai trial
A vaccine to prevent HIV infection has shown modest results for the first time, U.S. and Thai government researchers say. Results of a trial involving more than 16,000 volunteer participants in Thailand showed that those who received the vaccine were 31% less likely to contract HIV, compared with those on a placebo. Nearly 8,200 received a placebo and a similar number received a combination of six vaccines over six months. All were followed for three years. Fifty-one people in the vaccine group eventually contracted HIV, compared with 74 in the placebo group. The vaccine is a combination of Sanofi-Aventis' ALVAC canary pox vaccine and the failed HIV vaccine AIDSVAX, made by VaxGen and now owned by the nonprofit Global Solutions for Infectious Diseases. Researchers will announce details of their initial findings at the AIDS Vaccine Conference later this month in Paris, France.

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Got a management problem?
Send us your most puzzling problems on management, from dealing with budget cuts to cranky employees or bosses. Contact our Management Q&A editor, Anne Pontius, at manqa@mlo-online.com.
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Medicare may cover HIV tests
The Department of Health and Human Services (HHS) announced a proposal that would cover HIV testing for Medicare beneficiaries at increased risk for the infection, including women who are pregnant and Medicare beneficiaries of any age who voluntarily request the service. The CDC estimates that about 19% of all U.S. residents with AIDS were age 50 or older when they were diagnosed. HHS' Centers for Medicare & Medicaid Services will accept public comments on the proposed decision through Oct. 9, and will issue a final coverage decision by Dec. 8.

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Scientists explain HIV spread in Africa
Scientists studying biology and geography have joined to explain the spread of the HIV-1 epidemic in Africa. Writing in the October issue of AIDS, a research team led by scientists at the University of Florida explained why two subtypes of HIV-1 held steady at relatively low levels for more than 50 years in west central Africa before erupting as an epidemic in east Africa in the 1970s. The explanation for the HIV explosion involves the relative ease with which people can travel from city to city in east Africa as opposed to the difficulties faced by people living in the population centers of the Democratic Republic of Congo, the point where HIV emerged from west central Africa in its spread to the east. Investigators used databases, including GenBank from the National Center for Biotechnology Information, as well as DNA samples, including samples recently collected in Uganda — the vicinity where HIV entered east Africa — to follow the virus’ molecular footprints since its
emergence in the 1920s. Learn more at
www.news.health.ufl.edu.

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NAT gaining importance in infectious disease testing
The growing number of drug-resistant bacterial infections like MRSA may be the most important justification for nucleic-acid-based tests (NAT), according to the report “Infectious Disease Diagnostic Markets” from Kalorama Information. The needs of infectious-disease testing are such that culture-based assays and immunoassays are becoming increasingly inadequate, the report indicates, partly due to the increase in drug-resistant infections. NAT testing can be put to many uses, Kalorama Information’s publisher says, but what will get it into more labs is its role in determining the genetic differences that make a bacterial strain such as MRSA or MDR-TB/XDR-TB drug resistant, with results in two to four hours. What will cause immunoassays and culture-based assays to remain in the laboratory will be their relatively low cost. The cost of NAT assays, which are not usually analyzed outside the hospital lab, is still high. More information is available at
www.kaloramainformation.com.

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Academic doping could lead to urine tests for students
The increasing use of nootropics, or smart drugs, to boost academic performance, could mean students will face routine doping tests in future, suggests an article in the Journal of Medical Ethics. Nootropics were designed to help people with cognitive problems, such as dementia and attention deficit disorder, but students are using the drugs to achieve improvements in cognitive performance. The non-medical use of methylphenidate and amphetamine is as high as 25% on some U.S. college campuses, particularly in colleges with more competitive admission criteria, according to the article. Read more at http://jme.bmj.com.

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Got a testing problem?
Send us your most vexing problems on test methods, validation, reporting procedures, ornery instruments, and other technical questions. Contact our TIPS editor, Brad Karon, MD, PhD, at tips@mlo-online.com.
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INTERNATIONAL CORNER
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See the latest focus of MLO’s International Corner – NeTLIMS.
NeTLIMS Israel (Softov) kicked off its laboratory information systems (LIS) business in 1996, opened its U.S. headquarters in New Jersey in 2002, and today finds itself not only serving the second-largest health maintenance organization (HMO) in the world but also powering Quest Diagnostics’ operations in India. Read this month’s International Corner here.
Catch up with the August International Corner – Data Innovations.
If you are an American company conducting business with international presence and would like to be featured in this section of LABline, contact MLO’s editor at cbersch@nelsonpub.com for information on how to participate.
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INTERNATIONAL NEWS
Merck and QIAGEN to bring cervical cancer vaccination and screening to developing countries
Merck and QIAGEN are working together on a new program to increase access to HPV vaccinations and HPV DNA testing in some of the most resource-poor areas of the world. This collaboration will integrate Merck's cervical cancer vaccine, GARDASIL and QIAGEN's HPV tests, the digene HC2 HPV DNA Test (called the digene HPV Test) and a new HPV DNA test that is currently in development. Merck intends to provide, for free, up to 5 million doses of GARDASIL, and QIAGEN intends to add to its existing 1 million test donation program by providing HPV DNA tests to screen an additional 500,000 women. Merck and QIAGEN plan to seek other public and private partners to design and implement national public-sector cervical cancer programs, provide treatment as needed, and support improvements in laboratory and vaccine-delivery infrastructure, training of healthcare workers, education and advocacy. The participating countries will be announced once program details and implementation
strategies have been finalized. This program adds to QIAGEN’s April 2009 donation of 1 million HPV tests to low-income countries as part of the QIAGEN cares effort.
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Thermo Fisher Scientific acquires BRAHMS
Thermo Fisher Scientific has signed a definitive agreement to acquire BRAHMS AG for approximately $470 million to acquire the German company's line of diagnostic tests and expand its manufacturing presence in Europe. BRAHMS is a provider of specialty in-vitro diagnostic tests based on its patented biomarkers for sepsis, cardiovascular and pulmonary diseases, as well as intensive-care treatments and prenatal screening. BRAHMS is best known for its flagship product, Procalcitonin, a proprietary biomarker for the diagnosis and treatment of sepsis.
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bioMérieux helps fight antimicrobial resistance
The worldwide campaign Solutions to Manage the Antimicrobial Resistance Threat (S.M.A.R.T.), introduced by bioMérieux, is expected to create more educational resources for the lab and to provide healthcare professionals with tools and resources to identify, monitor, prevent, and track resistance. As part of its commitment to fight HAIs, bioMérieux has organized HAI symposia around the world including events in the United States, Belgium, the Netherlands, Portugal, Spain, Japan, and Korea throughout the past two years. Find out more at biomerieux-usa.com/smart.
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AWARDS
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IL announces “Passion & Results” award winners
In celebration of its 50th anniversary, Instrumentation Laboratory (IL) is recognizing individuals who have delivered remarkable results to improve patient care through their passion for diagnostic medicine. IL’s “Passion & Results” Award winners are:
- Dr. Cesare Manotti, President of the Italian Federation of Centers for the Surveillance of Anticoagulant therapies (FCSA) Milan, Italy;
- Giacinto Gervasi, MS, MT(ASCP), Lead Technologist, Laboratory Department, Syosset Hospital, Syosset, NY; and
- Diane Davis, MT(ASCP)SH, Clinical Laboratory Specialist, Pathology/Laboratory Medicine, All Children’s Hospital, St. Petersburg, FL.
Each winner received an award plus a $2,000 educational grant for their institution. For details and more information the winners and their stories, visit www.ilus.com/50forward.
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Anderson earns AACC CPOCT award
Marcy Anderson, MS, MT(ASCP) of Medical Automation Systems has been awarded with the Outstanding Contributions to Point of Care Testing Award by the AACC Division of Critical and Point of Care Testing. Anderson has advocated for point-of-care issues in various leadership positions throughout her career and has helped launch several programs, including the POC coordinator’s forum, the “Is the lab in the loop?” poster campaign, and the POC-specialist certificate program. |
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Diagnostic test wins medical technology award
Veridex CellSearch Circulating Tumor Cell (CTC) test was honored with the first-ever Prix Galien USA 2009 Award for Best Medical Technology. The CellSearch System is the first diagnostic test to automate the capture and detection of CTCs that have detached from solid tumors and entered the patient’s blood. This technology is used to predict overall survival and progression-free survival in patients with metastatic breast, colorectal, and prostate cancers. This test also was recognized by the Cleveland Clinic as the top medical innovation of 2009. The Prix Galien Award www.prix-galien-usa.com recognizes the technical, scientific, and clinical research skills necessary to develop innovative medicines. Prix Galien was established in 1970 by French pharmacist Roland Mehl and was inaugurated in the United States in September 2007. |
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Got a legal issue?
Send us your legislative questions, inquiries on human resource management legalities, and general problems on healthcare law. Contact our Liability and the lab editor, Barbara Harty-Golder, MD, JD, at toadehall@comcast.net.
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TO VIEW AN UPDATED LIST OF UPCOMING CONFERENCES, MEETINGS, EVENTS, AND WEBINARS, CLICK HERE.

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“Man is a creature composed of countless millions of cells: a microbe is composed of only one, yet throughout the ages the two have been in ceaseless conflict. ” —A.B. Christie

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