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.
ASM Posts LOCS Advisory on Measles Outbreak
On April 4, the ASM posted Laboratory Outreach Communications (LOCS) Advisory regarding the measles outbreaks in the United States. The LOCS Advisory was sent to ASM from the Centers for Disease Control and Prevention (CDC). The purpose of LOCS is to create a volunteer communications infrastructure for the exchange of laboratory related information between the CDC and others in the laboratory community.
Minority Microbiology Mentor Newsletter Available
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’s Communications Department is regularly scanning online news for coverage of the ASM as well as any of its products including meetings, journals, books, award or reports. A representative sample of the media coverage will be updated and can be read on ASM’s website.
Applications are currently being accepted for the National Registry of Microbiologists (NRM) exam which will be administered daily during the month of October at testing centers worldwide.
Food Microbiology, an Introduction, Second Edition (Authors: Thomas J. Montville, Karl R. Matthews). This textbook presents a classroom friendly adaptation that has been student tested for level and depth of coverage. This new edition offers a straightforward approach to learning the core principles without sacrificing depth, clarity, or rigor. It introduces the genetics and mechanisms important to specific issues in food microbiology.
Presentations from the ASM’s 108th General Meeting are now available for purchase including the PSAB sponsored session, “Biosafety and Your Laboratory: The Importance of Safety in Science.” Audio and presentation slides can be downloaded and CD-ROMs can be purchased.
Nominations for the Siemens Healthcare Diagnostics Young Investigator Award are currently being accepted. The award eligibility has been revised to honor nominees who are conducting outstanding research in clinical microbiology, automation in clinical laboratories, development of novel antimicrobial agents, mechanisms of action of antimicrobial agents or mechanisms of resistance to antimicrobial agents. The nomination deadline is on October 1, 2008.
Morbidity and Mortality Weekly Report – Articles of Interest
The Secretary of the Department of Health and Human Services, Michael Leavitt recently announced that the Centers for Disease Control and Prevention (CDC) awarded $12.9 million for the development of low cost influenza tests that can detect and differentiate seasonal human influenza viruses from avian influenza within three hours. These awards will support advanced development of laboratory influenza tests that could be performed in a hospital or a commercial laboratory and would expedite the diagnosis of large numbers of patients. The expanded testing capability would enhance the hospital laboratory based pandemic and seasonal flu diagnostic capacity in the United States.
The Government Accountability Office (GAO) released a new report, Healthcare Associated Infections in Hospitals (Report GAO-08-673T), which recommends that the Secretary of the Department of Health and Human Services (HHS) identify priorities among the recommended practices in Centers for Disease Control and Prevention (CDC) guidelines and establish greater consistency and compatibility of the data collected across HHS on Hospital Acquired Infections. The report examines 1) CDC’s guidelines to reduce or prevent hospital acquired infections (HAIs) and how HHS promotes guideline implementation; 2) the Centers for Medicare & Medicaid Services (CMS) and other accrediting organizations’ required standards for hospitals to reduce or prevent HAIs, and 3) HHS programs that collect data related to HAIs and integration of the HAIs across HHS.
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.
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.
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.
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
, 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
, 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
, 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?
, 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
, 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
, 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'
, 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
, 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
, 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
, 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
, 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.