On April 8, United States Federal District Court Judge, Thomas J. Whelan granted a preliminary injunction on the U.S. Department of Health and Human Services, prohibiting the Centers for Medicare & Medicaid Services (CMS) from announcing bid winners in the Medicare Competitive Bidding Demonstration for Clinical Laboratory Services. The preliminary injunction also enjoined CMS from otherwise implementing and carrying out the demonstration project in the San Diego metropolitan area, and further disclosing any information included in the bid applications. The decision was timely in that CMS was supposed to announce bid winners for the San Diego demonstration site on April 11. Because a preliminary injunction only delays the implementation of the demonstration until further Court order, it is critical that Congress act now to provide a permanent solution. ASM encourages you to contact your Members of Congress and urge them to co-sponsor and vote in favor of S. 2099, the Preserving Access to Laboratory Services Act of 2007 and H.R. 3453, the Community Clinical Laboratory Fairness in Competition Act of 2007.

ASM-CDC-APHL Meeting on Enteric Disease Testing Issues

On April 3-4, Vickie Baselski, chair of the Committee on Professional Affairs, and Bob Jerris, member of the Professional Affairs Committee represented ASM at a meeting to discuss the role of clinical diagnostic and public health laboratories in enteric disease surveillance and response, in Atlanta, GA. ASM was asked to cosponsor this year’s meeting with Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL). The ASM has two major action items from the 2008 meeting: the Society is participating in a workgroup helping to write the interpretation section of a Morbidity and Mortality Weekly Report Guideline on the issue, and the ASM is also responsible for gathering current coding, billing and compliance information on enteric diseases.

ASM Responds to Medically Unlikely Edits (MUE) Proposal

The ASM continues to comment on Medically Unlikely Edit (MUE) proposals regarding correct coding for Medicare laboratory testing based on appropriate utilization. The PSAB Committees on Professional Affairs and Laboratory Practices reviewed the MUE Phase VII proposal, and on April 7, the ASM submitted comments which included several edits for tests performed to detect infectious diseases by any method including molecular methods. The Phase VII edits are slated for a July 1 implementation date.

ASM Invited to Appoint Delegate to the USP

The ASM received a letter from the United States Pharmacopeia (USP), inviting the Society to appoint a delegate to the USP Convention, for a term that expires in 2010. The USP is a nonprofit, science based public health organization that maintains the US National Formulary and sets standards for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. Among its many responsibilities, the USP sets and maintains procedures for testing products for sterility, antimicrobial preservative effectiveness, and a number of other sentinel microbiology procedures. PSAB chair, Ruth Berkelman recommended to CPC the nomination of Alice Weissfeld, Ph.D., former chair and current member of the Committee on Professional Affairs, to serve as ASM’s delegate to the USP. The CPC approved Dr. Weissfeld’s nomination in early April.

The ASM Sentinel Clinical Laboratory Guideline on Burkholderia mallei and B. pseudomallei was recently revised and posted on ASM’s website. Peter Gilligan, Ph.D., and Mary York, Ph.D. are the authors of this guideline which can be downloaded from ASM’s Sentinel Level Clinical Microbiology Laboratory Guideline Webpage.

The April issue of the Minority Microbiology Mentor Newsletter has been published by the Committee on Microbiological Issues Impacting Minorities (CMIIM).

The ASM submitted FY 2009 funding recommendations to Congress on the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Science Administration, the U.S. Department of Agriculture, the Environmental Protection Agency and the Department of Energy. A compilation of the ASM recommendations to Congress as well as a budget analysis for the federal agencies that support R&D have been developed.

ASM News, Journal Articles and Updates

ASM 108th General Meeting The following is a list of sessions occurring at ASM’s 108th General Meeting in Boston that may be of interest to ASM’s clinical microbiology and public health members; please refer to the final program to verify meeting locations as rooms are subject to change. Opening Session - Microbiology in the 21st Century: Genomes, Pangenomes and Systems Biology (Session 001) Sunday, June 1, 5:00pm – 7:30pm, Seaport Exhibition Center   Status Update: Challenges with Gram-negative Antibiotic-Resistant Pathogens (009/C) Monday, May 2, 8:30am – 10:30am, Ballroom East   MRSA: What is the Role of Active Surveillance? (Session 013/L) Monday, June 2, 8:00am-10:30am, 205A   Climbing the Professional Ladder Without Falling Off (Session 022) Monday, June 2, 8:00am -10:30am, 104A   Division V Business Meeting (Clinical and Diagnostic Immunology) Monday, June 2, 10:45am – 11:45am, 258B   Division C Business Meeting (Clinical Microbiology) Monday, June 2, 12:00pm - 1:30pm, Ballroom East   Emerging Resistance Threats (Session 110/A) Monday, June 2, 8:00am – 10:30am, 210B   Tuberculosis: 21st Century View (Session 120/Y) Tuesday, June 3, 8:00am – 10:30am, 205A   Mycobacterium avium paratuberculosis: Incidental Human Pathogen or Public Health Threat? (Session 121) Tuesday, June 3, 8:00am – 10:30am, 104A   Division Y Business Meeting (Public Health) Tueday, June 3, 1:15pm – 2:15pm, 107A   Biosafety and Your Laboratory: The Importance of Safety in Science (Session 100) Tuesday, June 3, 2:30pm - 5:00pm, 104A   Emerging Infections (Session 098/Y) Tuesday, June 3, 2:30pm – 5:00pm, 205A   You are the Jury: The Microbiologist as Expert Witness - Real Cases with Real Attorneys (Session 112/C)  Tuesday, June 3, 8:00am-10:30am, Ballroom East   Case Presentations in Clinical Microbiology (Session 191/C) Tuesday, June 3, 2:30pm – 5:00pm, Ballroom East   Research Activities in Today's Clinical Microbiology and Immunology Labs: Life Beyond the Board Exams (Session 201) Tuesday, June 3, 2:30pm-5:00pm, 104A   President’s Forum: Pathogenic Mechanism for Avoidance of Host Recognition (Session 204) Tuesday, June 3, 5:30pm – 7:00pm, 253A   Coordination of Antimicrobial Susceptibility Surveillance Programs, Can It Be Done? (Session 253A) Wednesday, June 4, 8:00am-10:30am, 253A   Review of Current Performance of Automated Microbiology Systems (Session 216/C) Wednesday, June 4, 8:00am - 10:30am, Ballroom East   It’s a Small World After All: Global Threat of Foodborne Illness (Session 295) Wednesday, June 4, 2:30pm – 5:00pm, Ballroom West   Changing the Quality Control Requirements for Automated ID Systems (Session 299/C) Wednesday, June 4, 2:30pm - 5:00pm, 258B Clinical Microbiology is a Trivial Pursuit (Session 310) Wednesday, June 4, 2:30pm – 5:00pm, Ballroom East   Hidden Perils: Tackling Lab Biosafety (Session 313C) Thursday, June 5, 8:00am - 10:30am, 205A   The TB Laboratory in High-Burden, Low Resource Countries (Session 321/U) Thursday, June 5, 8:00am – 10:30am, 258B   Traditional Treatments of Infectious Diseases (Session 323) Thursday, June 5, 8:00am – 10:30am, 107A For more detailed information about these and other sessions, and click on the Program Viewer. New College Report: Clinical Microbiology in the 21st Century Download the Report The American College of Microbiology recently released its new report, Clinical Microbiology in the 21st Century. The report discusses the current status of clinical microbiology, the directions in which it is headed, and solutions for the problems of today and those likely to be encountered in the years to come. ASM Journal Articles of Interest Journals Tip Sheet   Immune Cells May Induce Gastritis During H. pylori Infection Infection and Immunity, May 2008   New Single-Dose Orthopoxvirus Drug in First Stage of Human Trials Antimicrobial Agents and Chemotherapy, May 2008   New Coronavirus Found in Beluga Whale Journal of Virology, May 2008   ASM Endorses “One Health” Initiative Press Release The American Society for Microbiology has endorsed the One Health Initiative, which recognizes the inter relationships among human, animal, and environmental health and seeks to enhance communication, cooperation, and collaboration in integrating these areas for the health and well being of all species. New from ASM Press E-store Campylobacter, 3rd Edition (Editors: Irving Nachamkin, Christine M. Szymanski, and Martin J. Blaser) was recently published by ASM Press. The understanding of clinical aspects, epidemiology, pathogenesis, genomic diversity, and glycobiology of Campylobacter infection has greatly increased. All of the new findings, knowledge, and research are brought together in the third edition of this publication. For more information, please visit ASM press at the ASM e-Store and click on ASM Press.   Federal Agency Updates SACGHS Final Report on Genetic Testing Oversight Released Download the Report The Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) released its final report, U.S. System of Oversight of Genetic Testing. The report provides a comprehensive map of the oversight system for genetic testing, identifies components of the system that need to be strengthened, urges enhanced interagency coordination of activities associated with the oversight of genetic testing, and recommends steps that could be taken by the public and private sectors to help assure public health and safety.   MMWR Update on Measles Download the Report Updated information regarding the number of reported measles cases in the United States was published in the May 1 issue of Morbidity and Mortality Weekly Report. The overall number of reported cases declined from 763,094 in 1958 to fewer than 150 cases reported per year since 1997. However, during January 1 - April 25, 2008, a total of 64 confirmed measles cases were reported to CDC, the most reported by this date for any year since 2001. Of the 64 cases, 54 were associated with importation of measles from other countries, and 63 patients were unvaccinated or had unknown or undocumented vaccination status. Human Rabies Prevention, 2008 Download the Report Morbidity and Mortality Weekly Report (MMWR) recently published the recommendations of the Advisory Committee on Immunization Practices (ACIP) on Human Rabies Prevention. The recommendations update the previous recommendations on human rabies prevention and provide the status of rabies and antirabies biologics in the United States. Included in the report is 1) updated information on human and animal rabies epidemiology; 2) the evidence regarding the effectiveness/efficacy, immunogenicity, and safety of rabies biologics; 3) new information on the cost-effectiveness of rabies postexposure prophylaxis; 4) recommendations for rabies postexposure and pre-exposure prophylaxis; and 5) information regarding treatment considerations for human rabies patients. Increased Detections and Severe Neonatal Disease Associated with Coxsackievirus B1 Infection, United States, 2007 Download the Report Recently published in Morbidity and Mortality Weekly Report, is an analysis of case reports and preliminary data from the National Enterovirus Surveillance System (NESS) to describe the severity of neonatal illness associated with coxsackievirus B1 (CVB1) infection. The report describes the results of that analysis, which indicated that, in 2007, CVB1 for the first time was the predominant enterovirus in the United States, accounting for 113 (25%) of 444 enterovirus infections with known serotypes. Viral Hepatitis Awareness Month MMRW - May 16  Hepatitis Foundation International  CDC Web Page on Hepatitis May 2008 marks the 13th anniversary of Hepatitis Awareness Month in the United States. May 19 was World Hepatitis Day, which recognized the importance of global commitments to prevent liver disease and cancer caused by viral hepatitis. The May 16 issue of Morbidity and Mortality Weekly Report (MMWR) included reports on an outbreak of acute hepatitis C associated with unsafe injection practices at an endoscopy clinic and a report on hepatitis C virus (HCV) infections among young injection-drug users. Both reports highlight the role of viral hepatitis surveillance in detecting outbreaks and populations at risk. Development of effective state and local surveillance for acute and chronic viral hepatitis is a public health priority. For more information on hepatitis, please visit the website of the Hepatitis Foundation International or the Centers for Disease Control and Prevention (CDC) webpage on hepatitis. National Conference on Laboratory Aspects of Tuberculosis  For More Information The Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL) are hosting the fifth annual National Conference on Laboratory Aspects of Tuberculosis (TB) in San Diego, California from August 11-13, 2008. The conference will focus on drug resistant TB, including drug susceptibility testing (DST) practice and standards for laboratories in the United States. Other topics will include new TB diagnostics, such as the use of molecular tests and interferon gamma release assays (IGRA); global laboratory implications and practice; national plan for laboratory systems; and laboratory integration into TB control.   Other Information and Updates Agents of Bioterrorism: Sentinel Training for Clinical Laboratories  For more information The National Laboratory Training Network (NLTN) is offering a one day, advanced level program to provide an overview of the clinical laboratory’s role in the presumptive identification of primary agents of bioterrorism including anthrax, plague, tularemia, brucellosis, glanders, and melioidosis. Laboratory demonstrations will outline the microbiology of these agents so that participants can recognize the culture, staining and biochemical characteristics. In addition, safety implications of handling suspect organisms in clinical isolates and culture and suspect toxins will be emphasized. Policies related to chain-of-custody specimens will also be reviewed. The meeting is scheduled to take place on May 15 in Columbus, GA.   New from CLSI To purchase CLSI Guidelines   MM17-A, Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline. This guideline provides recommendations for analytic verification and validation of multiplex assays, as well as a review of different types of biologic and synthetic reference materials. I/LA30-A, Immunoassay Interference by Endogenous Antibodies; Approved Guideline This guideline discusses the nature and causes of interfering antibodies, as well as their effects on immunoassays and mechanisms by which interference occurs. Methods to identify and characterize the interferences are addressed along with assessment of methods used to eliminate interference. M31-A3, Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Approved Standard, Third Edition This document provides the currently recommended techniques for antimicrobial agent disk and dilution susceptibility testing, criteria for quality control testing, and interpretive criteria for veterinary use. M37-A3, Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents; Approved Guideline, Third Edition This document addresses the required and recommended data needed for selection of appropriate interpretive standards and quality control guidance for new veterinary antimicrobial agents. World Malaria Day For more information   April 25, 2008 marks the first annual World Malaria Day. World Malaria Day was established and approved by the World Health Organization in March 2007, and replaces “Africa Malaria Day” which has been commemorated every year since 2001. The Malaria Consortium has been responsible for organizing events around the world to commemorate World Malaria Day. STD Awareness Month For more information The American Social Health Association (ASHA) and the National Coalition of STD Directors (NCSD) recognize April as National STD Awareness Month and emphasize testing as a key component for sexual health. According to ASHA, there are nearly 19 million new cases of sexually transmitted diseases (STDs) in the U.S. each year, but obvious symptoms often do not develop and many people who contract an STD are unaware they and their partners are at risk. The Centers for Disease Control and Prevention (CDC) recommends routine chlamydia testing for women under age 26, and for women who are pregnant or have new or multiple partners. CDC also recommends routine HIV testing for those ages 13-64.   Articles of Interest New kind of killer virus discovered in Bolivia New Scientist, April 18, 2008 A team of disease hunters has announced the discovery of a deadly new virus, found in a remote village in South America.   Revealed: the Asian source of the annual flu epidemic New Scientist, April 17, 2008 Now the biggest analysis of flu strains ever has shown it comes from eastern and Southeast Asia, a product of the connectedness of people and the patchiness of the region's rainy seasons.   First successful libraries of avian flu virus antibodies created  Science Daily, April 17, 2008 An international group of American and Turkish research scientists, led by Sea Lane Biotechnologies, has created the first comprehensive monoclonal antibody libraries against avian influenza (H5N1) using samples from survivors of the 2005/2006 "bird flu" outbreak in Turkey.   Lyme bacteria can 'hide' from medicine, study says San Mateo County Times, April 17, 2008 A recent study from the University of California, Davis, provides the first evidence that the bacteria causing Lyme disease can evade antibiotics by "hiding out" in tissue throughout the body and remain infectious long after treatment ends.   West Nile virus on the decline? Edmonton Sun, April 14, 2008 Last year was big for West Nile in Canada with 2,353 cases, mostly in the Prairie provinces, but there is a slight chance this year could see lower numbers, says Dr. Harvey Artsob, director of zoonotic diseases at Winnipeg's National Microbiology Laboratory.   USDA scientists say irradiation could be key to food safety Los Angeles Times, April 11, 2008 They say the process destroys E. coli and other potentially deadly microbes that chlorine doesn't kill in fruits and vegetables.   Bacteria tails could protect against 'dirty' bomb  New Scientist, April 11, 2008 A drug made out of Salmonella can protect mice and monkeys from high doses of radiation. It might help protect rescuers who have to enter a radioactive area after attack with a nuclear or "dirty bomb," and also cancer patients undergoing radiation therapy.   Getting jump on killer bacteria The Intelligencer, April 10, 2008 A four member team from Belleville hospital employed a new detection system called Agar to root out the deadly superbug VRE (Vancomycin-Resistant Enterococci) and there is no doubt that the process will save lives.   Cancer treatment from a common avian virus under study News-Medical.Net, April 7, 2008 Researchers on the Blacksburg and College Park, Maryland campuses of the Virginia-Maryland Regional College of Veterinary Medicine have been awarded a major new grant from the National Institutes of Health (NIH) to support innovative work that seeks to develop a treatment for cancer from a common avian virus.   Alligator blood 'may fight bugs'  BBC News, April 6, 2008 Proteins isolated from alligator blood may lead to new antibiotics to treat "superbugs" such as MRSA.   Mud harnessed to fight infection U.S. News & World Report, April 6, 2008 Researchers searched world, found 3 clays that beat back the toughest germs.   Deadly bug early detection hope  BBC News, April 4, 2008 Scientists have developed a method for quickly detecting a deadly superbug which infects weakened immune systems.   Single virus gene may cause obesity New Scientist, April 4, 2008 If obesity seems to be spreading like a virus, that could be because it is. We're now closer to understanding how adenovirus-36 (Ad-36), thought to be responsible for some cases of obesity, causes fat cells to grow.   Soil 'ultra-bugs' thrive on a diet of antibiotics New Scientist, April 3, 2008 Call them the "ultra-bugs," bacteria that are not merely resistant to antibiotics, but feed on them. They lurk in dirt from parks, farms and gardens. While the ultra-bugs don't normally cause disease, researchers are concerned the bacteria might pass drug resistance onto their deadly kind.   Thousands hit by Brazil outbreak of dengue CNN, April 3, 2008 More than 55,000 cases of dengue, a sometimes deadly mosquito-borne disease, have been reported in a southeastern Brazilian state in the past four months.   Scientists uncover how HIV hides inside cells U.S. News & World Report, April 1, 2008 U.S. researchers say they've discovered how HIV, the virus that causes AIDS, hides in human cells to avoid being destroyed by the body's immune cells.