- PSAB Regulatory Alert to Members on Changes to Select Agent Regulations
- ASM Receives the APHL Award for Excellence in Developing LRN Scientific Guidelines
- ASM Staff Trained in The Joint Commission New Portal for Accredited Labs
- ASM Staff Attends PCAST Report Release Event
- ASM Participates in NCEZID’s First Strategic Plan Release
- ASM Staff Participates in Teaching Laboratories Biosafety Conference Call
- ASM Congressional Science Fellow Placement
- Minority Microbiology Mentor Newsletter
ASM NEWS, JOURNAL ARTICLES AND UPDATES
- ASM Conferences
- ASM Journal Articles of Interest
- Professional Practice Committee Anniversary
FEDERAL AGENCY UPDATES
- CDC Responds to Multistate Fungal Meningitis Outbreak
- TEST Act Headed for November Congressional Session
- CMS Announces New Waived Tests and Billing Codes
- CDC Releases First FluView Report for 2012-2013 Influenza Season
- NIH-Funded Study to Test Pneumococcal Vaccine in Older Adults
- MMWR Articles of Interest
OTHER INFORMATION AND UPDATES
- Guidance on Management of Asymptomatic Patients Who Received Epidural or Paraspinal Injections with Contaminated Steroid Product
- IDWeek: A Joint Meeting of IDSA, SHEA, HIVMA, and PIDS
- APHL Select Agent Regulatory Update Webinar
- Articles of Interest
PSAB Regulatory Alert to Members on Changes to Select Agent Regulations
The PSAB sent a regulatory alert to members on October 17 to inform them of important changes to the select agent regulations. The Department of Health and Human Services (HHS) and the USDA Animal and Plant Health Inspection Service (APHIS) published regulatory changes to the Select Agent and Toxin rules in the October 5, 2012 Federal Register. The final rule changes implement the findings of the third biennial review of the Select Agent and Toxin lists and modifies the list of Select Agents and Toxins, to designate a subset of the list as Tier 1 based on their risk to be deliberately misused. This changes security requirements for entities possessing Tier 1 Select Agents and Toxins and specifically addresses diagnostic laboratories on page 61064. Highlights of the changes are summarized and posted on the ASM Public Policy webpage at: http://asm.org/index.php/public-policy-2/97-policy/documents/8417-sa-10-9-12.
ASM Receives the APHL Award for Excellence in Developing LRN Scientific Guidelines
The Association of Public Health Laboratories (APHL) recognized the ASM with the Award for Excellence in Developing Scientific Guidelines on October 10 at their 2012 Laboratory Response Network (LRN) National Meeting in Denver, CO. This award is given to an organization which has made significant contributions to the advancement of LRN practices and policies, positively influencing the network and its members. For over a decade, ASM has maintained the Sentinel Level Clinical Microbiology Laboratory Guidelines for Suspected Agents of Bioterrorism and Emerging Infectious Diseases and continues to make improvements to these important guidelines, which are used by all Sentinel laboratories. Committee on Laboratory Practices member James Snyder received the award for ASM. Dr. Snyder represents ASM in the LRN and is assisted by Alice Weissfeld of the Professional Affairs Committee. The LRN was established in accordance with Presidential Decision Directive 39 in 1999 to improve US readiness for bioterrorism and is equipped to respond to acts of biological terrorism, emerging infectious disease, and other public health threats. To see the current guidelines, visit http://www.asm.org/index.php/issues/sentinel-laboratory-guidelines. For more information on the LRN, see http://emergency.cdc.gov/lrn/.
ASM Staff Trained in The Joint Commission New Portal for Accredited Labs
In August, The Joint Commission announced the launch of Lab Central Connect™ for accredited laboratories. The portal is designed to help Joint Commission-accredited laboratories centralize storage of important survey-related documents, as well as improve safety and quality by helping to maintain continuous compliance with Joint Commission standards. A distance training exercise occurred during the 19 September Laboratory Professional and Technical Advisory Committee Members (LAB PTAC) conference call to acquaint members with the resources available through the portal. ASM’s LAB PTAC Representative Yvette McCarter, from the Committee on Laboratory Practices and ASM Staff took part in the training. To read more about Lab Central Connect™, go to http://www.jointcommission.org/lab_central_connect_portal/.
ASM Staff Attends PCAST Report Release Event
On September 25, the President’s Council of Advisors on Science and Technology (PCAST) released its Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation in partnership with and hosted by the Institute of Medicine (IOM) and the National Academy of Sciences (NAS) in Washington, DC. The speakers for the event included PCAST Co-Chairs John Holdren, Advisor to the President for Science and Technology, and Eric Lander; and Margaret Hamburg, the Commissioner of the Food and Drug Administration (FDA). You read can this report, and others from PCAST, by going to the link http://www.whitehouse.gov/administration/eop/ostp/pcast/docsreports. The ASM is a cosponsor of the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation. The Forum sponsors meetings with leaders from federal agencies, non-profit associations and the private sector to discuss issues related to drug discovery and regulatory approval to translation of research into clinical practice. More information on the Forum and links to its reports are available on-line at: http://www.iom.edu/Activities/Research/DrugForum.aspx.
ASM Participates in NCEZID’s First Strategic Plan Release
The Center for Disease Control and Prevention’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) released its first strategic plan since the Center’s inception in 2010. ASM staff participated in the October 16 conference call to offer input on collaboration and implementation of the plan, which is posted on the NCEZID website at http://www.cdc.gov/ncezid/. The plan lays out the priority work for the Center for the next 5 years (2012-2017) with four strategies. The strategies and objectives build upon the principles described in CDC’s Office of Infectious Diseases’ A CDC Framework for Preventing Infectious Diseases: Sustaining the Essentials and Innovating for the Future, which serves as a roadmap for all of CDC’s infectious disease work.
ASM Staff Participates in Teaching Laboratories Biosafety Conference Call
ASM staff participated in a Bi-National Laboratory Associated infection (LAI) Working Group Conference Call on October 2 which discussed the draft Guidelines for Best Biosafety Practices in Teaching Laboratories. To help educators and students safely work with microbes in their courses as well as reduce the likelihood of laboratory-acquired infections, the ASM Task Committee on Laboratory Biosafety drafted these comprehensive guidelines; there are two sets of guidelines, one for labs handling organisms at biosafety level 1 (BSL1), and another for those working at BSL2. ASM members were able to submit comments to the draft guidelines until October 15, 2012. Stakeholders from Canada and the United States participated in the call which reported the input from attendees at the annual ASMCUE meeting in June and the Division W business meeting at the 2012 General Meeting. Most of the comments reported as well as those from the stakeholders on the call addressed whether the guidelines would recommend or direct strict adherence and if they would be used internationally. A second concern was focused on the cost of implementation of the guidelines in teaching laboratories, particularly, the cost of disposable gloves and other consumables.
ASM Congressional Science Fellow Placement
Kristen E. Shatynski, Ph.D., ASM’s 2012-2013 Congressional Science Fellow has found a placement in the office of Representative Devin Nunes (R-CA). The ASM Congressional Science Fellowship Selection Committee selects a postdoctoral to mid-career microbiologist to spend one year on the staff of an individual congressman, congressional committee, or with some other appropriate organizational unit of Congress. Prospective Fellows must be citizens of the United States, members of ASM for at least one year and must have completed their Ph.D. by the time the fellowship begins in September. The Congressional Science Fellowship is supported in part by the Frobisher Fund, a bequest made to ASM by Martin Frobisher, and has been in existence since 1977. Contact the Office of Public Affairs at firstname.lastname@example.org for more information on the ASM fellowship or go to the ASM web page for a program description: http://asm.org/index.php?option=com_content&view=article&id=7535. The deadline for applications for the 2013 – 2014 fellowship is February 22, 2013.
Minority Microbiology Mentor Newsletter
The October issue of the Minority Microbiology Newsletter has been published by the Committee on Microbiological Issues Impacting Minorities. You can read the newsletter by going to this link: http://asm.org/index.php/documents/public-policy-newsletters/134-policy/documents/newsletters/e-public-policy-update/8466-mmm-10-12
ASM NEWS, JOURNAL ARTICLES AND UPDATES
4th ASM Conference on Beneficial Microbes
October 22-25, 2012
San Antonio, TX
For a complete list of upcoming ASM conferences, please see http://conferences.asm.org/
ASM Journal Articles of Interest
Antibodies to Immune Cells Protect Eyes in Pseudomonas Infection
Contact lenses, particularly the extended wear variety, render wearers vulnerable to eye infections from Pseudomonas aeruginosa. These infections can cause severe damage, including blindness. Treating the eye with antibodies to the inflammatory immune compound, interleukin-17 (IL-17) reduced eye damage and the number of bacteria in a mouse model. The research is published in the October Infection and Immunology.
Dangerous Form of MRSA, Endemic In Many US Hospitals, Increasing in UK
Prevalence of a particularly dangerous form of methicillin resistant Staphylococcus aureus (MRSA) jumped three-fold in just two years, in hospitals in the United Kingdom, according to a paper in the October 2012 Journal of Clinical Microbiology. The MRSA in question contains a toxin called Panton-Valentine leukocidin (PVL), which destroys leukocytes, kills skin and mucus membranes, and confers increased virulence.
New Agent against MDR Biofilms
Researchers have shown that a low-molecular-weight, alginate nanomedicine known as OligoG can boost the effıcacy of conventional antibiotics up to 512-fold against multidrug resistant pathogens including Pseudomonas, Acinetobacter, and Burkholderia species.
Restricted Gene Flow among Hospital Subpopulations of Enterococcus faecium
Enterococcus faecium has emerged recently as an important pathogen in antibiotic resistant hospital acquired infections. Defining population structure in this species provides insight into the existence, distribution, and dynamics of specific lineages in particular environments, like the hospital. This article reports the population structure of E. faecium using Bayesian-based population genetic modeling implemented in Bayesian Analysis of Population Structure (BAPS) software.
Professional Practice Committee Anniversary
ASM established the Professional Practice Committee (PPC) in 2011 as a Standing Committee of the Council Policy Committee, ASM’s Executive Leadership Board. The PPC’s mission is to oversee ASM’s professional activities, provide a mechanism for coordinated communication with members and ASM leadership, and advocate for the professional needs of practitioners.
As the PPC concludes its first year of service, it is an opportune time to provide members with an annual report of ASM’s recent clinical activities. It is available online at http://asm.org/images/PPC/div1_2012_update.pdf.
FEDERAL AGENCY UPDATES
CDC Responds to Multistate Fungal Meningitis Outbreak
On October 4th, CDC’s Emergency Operations Center was activated in response to the Multi-State Meningitis Outbreak. CDC is investigating the multistate non-contagious fungal meningitis outbreak among patients who received contaminated steroid injections. The investigation also includes fungal infections associated with injections in a peripheral joint space, such as knee, shoulder or ankle. CDC’s roles have included: working with states to track down and call every person who received an injection from one of the three tainted lots; analyzing laboratory samples from affected patients; making recommendations for doctors and patients based on incoming data; coordinating with other federal and state health officials; and developing content to be shared through the media, the CDC website, social media, and partners. For the latest see http://www.cdc.gov/HAI/outbreaks/meningitis.html
TEST Act Headed for November Congressional Session
Legislation giving CMS more flexibility in levying sanctions on clinical laboratories for referring proficiency testing (PT) samples is scheduled for a vote in the lame duck congressional session scheduled to begin November 13. The TEST Act (H.R 6118) passed the House in September, but its companion Senate bill, S. 3391, cleared the Senate Health, Education, Labor and Pensions (HELP) Committee on September 19, just two days before the Senate adjourned until after the November 6 election. To read the text of the Senate bill, see http://www.gpo.gov/fdsys/pkg/BILLS-112s3391rs/pdf/BILLS-112s3391rs.pdf
CMS Announces New Waived Tests and Billing Codes
On Oct 1, The Centers for Medicare and Medicaid Services (CMS) updated the list of (CLIA) waved tests. The updated list includes eleven new FDA approved waived tests and include tests for Influenza A+B, H. pylori, and Strep A. To see the updated list, please go to http://www.cms.gov/Regulations-and-guidance/Guidance/transmittals/downloads/R2496CP.pdf
CDC Releases First FluView Report for 2012-2013 Influenza Season
The CDC issued the first “FluView” influenza activity report for the U.S. 2012-2013 flu season on October 12. The 2012-2013 reporting season began on September 30. The first FluView report shows that influenza activity is low nationwide. This season, FluView has new interactive visualization tools. For more, see http://www.cdc.gov/media/releases/2012/a1012_flu_view_report.html
NIH-Funded Study to Test Pneumococcal Vaccine in Older Adults
Researchers plan to see if a higher dose of a pneumococcal vaccine will create a stronger immune response in older adults who received an earlier generation vaccine against pneumonia. The study will compare two dosages of a pneumococcal vaccine approved for children ages 6 weeks to 5 years, and adults 50 and older and will enroll up to 882 men and women ages 55 to 74. For more, see http://www.niaid.nih.gov/news/newsreleases/2012/Pages/PneumococcalVaccine.aspx
MMWR Articles of Interest
Multistate Outbreak of Fungal Infection Associated with Injection of Methylprednisolone Acetate Solution from a Single Compounding Pharmacy: United States, 2012
On September 18, the Tennessee Department of Health (DOH)was alerted by a clinician regarding a patient with culture-confirmed Aspergillus fumigatus meningitis diagnosed 46 days after epidural steroid injection at a Tennessee ambulatory surgical center. By September 27, the initial investigation, carried out by the Tennessee DOH in collaboration with CDC and the North Carolina Department of Health and Human Services, had identified an additional eight patients with clinically diagnosed, culture-negative meningitis: seven in Tennessee and one in North Carolina. All nine patients had received epidural steroid injection with preservative-free methylprednisolone acetate solution (MPA), compounded at New England Compounding Center (NECC) in Framingham, Massachusetts. All nine patients had received one or more injections from three lots of MPA (lot numbers 05212012@68; 06292012@26; and 08102012@51).
Announcement: World Polio Day: October 24, 2012
World Polio Day was established by Rotary International to commemorate the birth of Jonas Salk, who led the first team to develop a vaccine against poliomyelitis. Use of this inactivated poliovirus vaccine and subsequent widespread use of the oral poliovirus vaccine developed by Albert Sabin led to establishment of the Global Polio Eradication Initiative (GPEI) in 1988.
Botulism From Drinking Prison-Made Illicit Alcohol: Utah 2011
During October 2–4 2011, eight maximum security inmates at the Utah State Prison in Salt Lake County were diagnosed with foodborne botulism. An investigation by Salt Lake Valley Heath Department, Utah Department of Health, and CDC identified pruno, an illicit alcoholic brew, as the vehicle. The principal ingredients in pruno are fruit, sugar, and water; root vegetables, are sometimes added, if available. A baked potato saved from a meal served weeks earlier and added to the pruno was the suspected source of C. botulinum spores.
Notes from the Field: Tuberculosis Outbreak in a Long-Term–Care Facility for Mentally Ill Persons: Puerto Rico, 2010–2012
During January 2012, the Puerto Rico Department of Health (PRDOH) detected a tuberculosis (TB) outbreak among residents of a long-term–care facility in the San Juan metropolitan area. The same rare Mycobacterium tuberculosis genotype was identified in isolates from four patients. This facility housed 40 men, aged 40–71 years, with severe mental illness. During April 2012, CDC assisted PRDOH with the investigation to describe outbreak epidemiology, identify and prioritize contacts for evaluation and treatment, and provide recommendations on interventions aimed at stopping TB transmission.
Announcement: Application Deadline for The CDC Experience Applied Epidemiology Fellowship is December 7
The CDC Experience is a 1-year fellowship in applied epidemiology for third- and fourth-year medical students. Eight competitively selected fellows spend 10–12 months at CDC in Atlanta, Georgia, where they conduct epidemiologic analyses in areas of public health of their choice. Information on applying for The CDC Experience is available at http://www.cdc.gov/cdcexperiencefellowship. Applications for the class of 2013–14 must be submitted by December 7.
OTHER INFORMATION AND UPDATES
Guidance on Management of Asymptomatic Patients Who Received Epidural or Paraspinal Injections with Contaminated Steroid Products
The Centers for Disease Control and Prevention (CDC) continues to assess and revise interim guidance to clinicians involved in the management of patients who received injections with contaminated steroid products distributed by the New England Compounding Center (NECC). Since early in the outbreak, CDC has recommended against antifungal prophylactic or presumptive treatment of exposed asymptomatic patients in the absence of diagnostic testing with results indicating meningitis. To see the full update, go to: http://emergency.cdc.gov/HAN/han00330.asp
IDWeek: A Joint Meeting of IDSA, SHEA, HIVMA, and PIDS
IDWeek 2012TM was held October 17-21; it was a joint meeting of the The Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), The HIV Medicine Association (HIVMA), and the Pediatric Infectious Disease Society (PIDS). With the theme “Advancing Science, Improving Care,” IDWeek featured the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment, and epidemiology of infectious diseases, including HIV, across the lifespan. For a recap of the conference, please see http://www.idweek.org/.
APHL Select Agent Regulatory Update Webinar
December 4, 2012 • 1:00–2:00 pm ET
This presentation will discuss recent proposed changes of the CDC Select Agent and Import Permit Regulations. At the conclusion of the program, the participant will be able to discuss the proposed changes to the select agent and import permit regulations. For more information, see the flyer at http://www.aphl.org/courses/Documents/2012/588-931-12-SelAgt.pdf
Articles of Interest
Tainted Drug Passed Lab Test
Wall Street Journal
October 24, 2012
The Massachusetts specialty pharmacy linked to a deadly meningitis outbreak had its products tested at an independent lab, which in May stated that samples from a batch of steroids—later implicated in the meningitis—were "sterile," according to documents reviewed by The Wall Street Journal.
TB Immune to Drugs Proves Hard to Detect
Wall Street Journal
October 18, 2012
Drug-resistant tuberculosis is going largely undetected in many countries, threatening progress made against the pernicious lung disease over the past decade, according to data in a recently released World Health Organization report.
Meal of Black bear Meat Leads to Rare Trichinosis Infection for Alaska Man
The Kansas City Star
October 26, 2012
The black bear meat tasted delicious. Sean Sullivan didn't know it would give him trichinosis. Trichinosis is caused by eating raw or undercooked meat infected with the larvae of the parasite Trichinella, which reproduces and eventually travels through arteries to become cysts in muscle tissue.
Burns field Closed 6 Months After Goat Prank
The Charlotte Observer
October 26, 2012
The football field at Burns High School in Cleveland County (NC) will be closed for most of the rest of the school year, following a prank last week in which someone turned goats loose in the facility. The six-month closure is out of caution over a recent E. coli outbreak in the county, according to school and state health officials.