Clinical Microbiology Issues Update - September 2015

PSAB ACTIVITIES

  • ASM Comments on Cost Increase for the Drug Daraprim
  • ASM Sends Letter to Members of Congress on Antibiotic Tax Credit Bill
  • ASM Sends Questions to CMS on Implementation of IQCPs
  • ASM Updates Select Bacterial LRN Protocols
  • ASM Participates in S-FAR Summer Series
  • ASM Comments on the List of Select Agents and Toxins
  • ASM Comments on the Framework for the NIH-wide Strategic Plan
  • ASM Comments on State and Commerce Department Control Regulations for Certain Pathogens
  • ASM Posts DoD Statement on Anthrax Shipment to Labs Worldwide
  • ASM Presents at Annual CMS Clinical Lab Fee Schedule Meeting
  • FedEx Discontinues Transport of Select Agents
  • Minority Microbiology Mentor Newsletter

ASM NEWS, JOURNAL ARTICLES AND UPDATES

  • Stefano Bertuzzi Named New ASM Executive Director/CEO
  • Clinical Microbiology Photo Quiz
  • Hot Topic
  • ASM, CLIA and CAP Provide Additional IQCP Examples
  • ASM Conferences
  • ASM Journal Articles of Interest
  • ASM Press
  • Articles of Interest

FEDERAL AGENCY UPDATES

  • Researchers Find Role for Soft Palate in Adaptation of Transmissible Influenza Viruses
  • FDA Takes Steps in Modernizing the Food Safety System
  • CDC Revises Liberia Travel Alert from Level 2 to Level 1
  • CDC Grand Rounds: Shifts in Global Health Security; Lessons from Ebola
  • Gut Bacteria May Direct Immune Cell Attack in Eye Disorder
  • CDC Modeling Projects Growth of Drug-Resistant Infections and C. difficile
  • MMWR Articles of Interest

OTHER INFORMATION AND UPDATES

  • IDWeek2015
  • ASCP 2015: Beyond the Lab
  • Articles of Interest

PSAB ACTIVITIES

ASM Comments on Cost Increase for the Drug Daraprim
On September 22, ASM sent a letter to Tom Evegan and Kevin Bernier of Turing Pharmaceuticals to ask them to reconsider their pricing strategy for pyrimethamine (Daraprim) in the interest of public health. Read the letter at http://www.asm.org/index.php/public-policy/137-policy/documents/statements-and-testimony/93756-pyrimethamine-9-22.

ASM Sends Letter to Members of Congress on Antibiotic Tax Credit Bill
ASM sent a letter to Representatives Boustany and Thompson, the cosponsors of the now introduced H.R. 3539, “Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act of 2015”. To see the letter, please go to  http://www.asm.org/index.php/public-policy/137-policy/documents/statements-and-testimony/93751-ar-taxcredit.

ASM Sends Questions to CMS on Implementation of IQCPs
On September 8, the ASM Committee on Laboratory Practices sent questions to Andrew Slavitt, Acting Administrator, Centers for Medicare and Medicaid Services (CMS) about the implementation of Individualized Quality Control Plans (IQCPs) in the clinical microbiology laboratories.  As ASM has been assisting clinical microbiology personnel in preparing for the January 2016 deadline, several issues have been raised, which were addressed in the questions, which can be found at http://www.asm.org/index.php/public-policy/137-policy/documents/statements-and-testimony/93728-iqcp-cms.

ASM Updates Select Bacterial LRN Protocols
In August, several of the bacterial “Sentinel Level Clinical Laboratory Protocols for Suspected Biological Threat Agents and Emerging Infectious Diseases” were updated to include instructions for laboratories using MALDI-TOF for bacterial identification.  To see the complete list of protocols, go to http://www.asm.org/index.php/issues/sentinel-laboratory-guidelines

ASM Participates in S-FAR Summer Series
On September 1, The U.S. Stakeholder Forum on Antimicrobial Resistance (S-FAR) held a face to face meeting in Washington, DC with the stakeholders, which ASM staffers attended.   In addition, three webinars were held: “Antimicrobial Stewardship and Data Collection Components of the National Action Plan - Human Medicine” on July 15; "Stewardship, Data Collection, and Research Components of the National Action Plan - Veterinary Medicine" on July 30; and "Research & Development (R&D) and Incentive Components of the CARB National Action Plan" on August 20.  S-FAR is a national partnership convened by the Infectious Diseases Society of America (IDSA) consisting of over 70 national health organizations.  You can learn more by going to http://www.s-far.org/.

ASM Comments on the List of Select Agents and Toxins
ASM commented on the document “Possession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins” on August 24.  To see the statement, see https://www.asm.org/index.php/publicpolicy-2/statements-testimony/137-policy/documents/statements-and-testimony/93640-sa-8-24-15.   

ASM Comments on the Framework for the NIH-wide Strategic Plan
On August 17, ASM released detailed comments on the Request for Information (RFI) Inviting Comments and Suggestions on a Framework for the NIH-wide Strategic Plan.  In response to a request from the Congress, NIH is developing a 5-year NIH-wide Strategic Plan to advance its mission to support research in pursuit of fundamental knowledge about the nature and behavior of living systems, and the application of that knowledge to extend healthy life and reduce illness and disability.  To read ASM’s comments, go to https://www.asm.org/index.php/publicpolicy-2/statements-testimony/137-policy/documents/statements-and-testimony/93633-nih-sp-8-17-15

ASM Comments on State and Commerce Department Control Regulations for Certain Pathogens
The American Society for Microbiology commented on the ongoing efforts by the US Departments of State Commerce to update and clarify federal control regulations for Category XIV materials (Toxicological Agents, Including Chemical Agents, Biological Agents, and Associated Equipment).  To read the comments and learn more about the regulations, go to http://www.asm.org/index.php/public-policy-2/137-policy/documents/statements-and-testimony/93632-bis-8-17-15.   

ASM Posts DoD Statement on Anthrax Shipment to Labs Worldwide
The U.S. Department of Defense (DoD) inadvertently shipped samples containing live Bacillus anthracis, the causative agent of anthrax,and requested that the ASM post a statement on its website with information about that event. DoD performed a Comprehensive Review and had a press conference on July 23 to address the results of the investigation.  To see the statement, please go to http://www.asm.org/index.php/public-policy/93-policy/93545-dod-6-4-15.

ASM Presents at Annual CMS Clinical Lab Fee Schedule Meeting
On July 16, ASM presented comments at the annual Public Meeting Regarding the Clinical Laboratory Fee Schedule for CY 2016 at the Centers for Medicare & Medicaid Services (CMS) in Baltimore, MD.  This meeting allows stakeholder input on the basis of payment and the amount of payment by CMS for clinical laboratory tests introduced each calendar year.  To read ASM comments and see the meeting agenda, please go to http://www.asm.org/index.php/public-policy-2/137-policy/documents/statements-and-testimony/93598-clfs-7-15.    

FedEx Discontinues Transport of Select Agents
On July 17, FedEx notified federal agencies that they would no longer accept Select Agents for transport on FedEx Express.   Because FedEx is a large multi-national shipping company, many laboratories that identify and ship biological select agents and toxins may be affected by this decision.  Recently, a national medical courier organization assembled a list of couriers who offer transport of medical specimens, many of them willing to carry Select Agents.  To see this list, click the link and join https://integritydelivers.webconnex.com/MedCourierCnxMemberList.

Minority Microbiology Mentor Newsletter
The September 2015 issue of the Minority Microbiology Newsletter has just been published by the Committee on Microbiological Issues Impacting Minorities (CMIIM).  You can read the newsletter by going to this link: https://www.asm.org/index.php/publicpolicy-2/newsletters/minority-microbiology-newsletter/135-policy/documents/newsletters/minority-microbiology-mentor-newsletter/93739-mmm-9-15.

ASM NEWS, JOURNAL ARTICLES AND UPDATES

Stefano Bertuzzi Named New ASM Executive Director/CEO
Stefano Bertuzzi, Ph.D., MPH, has been named Executive Director/CEO of the American Society for Microbiology, effective January 4, 2016.  Dr. Bertuzzi comes from the American Society for Cell Biology (ASCB), where he serves as Executive Director.  Read more about the changes coming, by going to http://www.asm.org/index.php/asm-newsroom2/press-releases/93734-stefano-bertuzzi-named-executive-director-ceo-of-the-american-society-for-microbiology.

Clinical Microbiology Photo Quiz
The photo quiz is a popular feature from the Journal of Clinical Microbiology.  Test your skill at identification by going to https://clinmicro.asm.org/index.php/bench-work-resources/guidelines/22-identifying-organisms/399-photo-quizzes.    

Hot Topic
The August Hot Topic discussion, "Non-Tuberculous Mycobacterium sp.: What’s New in 2015?" was presented by Gerri S. Hall.  Members can see this presentation by going to https://clinmicro.asm.org/index.php/portal/hot-topics.

ASM, CLIA and CAP Provide Additional IQCP Examples
The ASM, CAP, CLSI Working Group on IQCP completed additional examples of documents for Commercial AST Systems, Disk Diffusion Testing, Commercial ID Systems and Exempt Culture Media.  To see what’s posted, go to http://clinmicro.asm.org/index.php/lab-management/laboratory-management/445-iqcp-iqcp.

ASM Conferences

7th ASM Conference on Biofilms
October 24-29, 2015
Chicago, IL

4th ASM-ESCMID Conference on Methicillin-resistant Staphylococci in Animals: Veterinary and Public Health Implications
November 2-5, 2015
Chicago, IL

@ASM Conference on The Individual Microbe: Single-cell Analysis and Agent-based Modeling
March 18-20, 2016
Washington, DC

For a complete list of upcoming ASM conferences, please see http://conferences.asm.org/.    

ASM Journal Articles of Interest

New Virus Identified in Blood Supply
Scientists have discovered a new virus in the blood supply. The pathology of the virus is unknown, but it is related to both hepatitis C virus (HCV) and human pegivirus (HPgV).  The new virus, which researchers have named human hepegivirus-1 (HHpgV-1), is described in the September 22 issue of mBio.  Read more about HHpgV-1 at http://www.asm.org/index.php/journal-press-releases/93757-new-virus-identified-in-blood-supply

Bordetella parapertussis Outbreak in Southeastern Minnesota in 2014
A new study reports that an outbreak of Bordetella parapertussis occurred in 2014 in Southeastern Minnesota, between October and December.  One interesting finding is that all children involved in the outbreak were up to date with their pertussis vaccines.  Read more about this outbreak by going to http://www.asm.org/index.php/asm-newsroom2/press-releases/93691-bordetella-parapertussis-outbreak-in-southeastern-minnesota-in-2014.

Leptospirosis in New York City: A Risk from Rats to Dogs and People
In New York City, leptospirosis, a bacterial disease that affects humans and animals, is most often spread to both people and dogs from rats, according to a study presented at the 2015 International Conference on Emerging Infectious Diseases.  To read more about the spread, see http://www.asm.org/index.php/asm-newsroom2/press-releases/93606-leptospirosis-in-new-york-city-a-risk-from-rats-to-dogs-and-people.

ASM Press

Manual of Clinical Microbiology, 11th Edition
Editors:  James H. Jorgensen and Michael A. Pfaller
Two-Volume Hardcover Set, 2,900 pages (est), full-color illustrations, index.
(ISBN: 9781555817374)  For more information, please visit the e-store at: http://www.asmscience.org/content/book/10.1128/9781555817381.  

Articles of Interest

Molecular Methods for Identification and Characterization of Novel Papillomaviruses
Authors provide a detail review of the contemporary molecular methods used for identification and characterization of novel PV types, including PCR, rolling circle amplification and next-generation sequencing. 

Evaluation of Factors Affecting Real-Time PCR Performance for Diagnosis of Entamoeba histolytica and Entamoeba dispar in Clinical Stool Samples
Although PCR offers the potential for sensitive detection of parasites there are several pitfalls for optimal performance, especially when DNA is extracted from a complex sample material like stool. With the aid of a sensitive inhibitor control in a duplex real-time PCR (qPCR) for identification of Entamoeba histolytica and Entamoeba dispar researchers have evaluated factors that influenced the performance of the qPCR and have suggested a rationale to be used in the analysis of clinical samples.

FEDERAL AGENCY UPDATES

Researchers Find Role for Soft Palate in Adaptation of Transmissible Influenza Viruses
National Institutes of Health scientists and their colleagues identified a previously unappreciated role for the soft palate during research to better understand how influenza viruses acquire the ability to move efficiently between people in studies using ferrets.  Read more about this study at http://www.niaid.nih.gov/news/newsreleases/2015/Pages/palateRole.aspx.  

FDA Takes Steps in Modernizing the Food Safety System
The U.S. Food and Drug Administration (FDA) took significant steps to prevent foodborne illness by finalizing the first two of seven major rules under the bipartisan FDA Food Safety Modernization Act (FSMA).  The FDA is now holding imported food to the same food safety standard as domestically produced food, and developing a nationally integrated food safety system in partnership with state and local authorities. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm461437.htm

CDC Revises Liberia Travel Alert from Level 2 to Level 1
Effective September 3, 2015, the Centers for Disease Control and Prevention (CDC) have downgraded the travel notice for Ebola in Liberia to a Watch Level 1; this means the recommendation for U.S. residents traveling to Liberia are to practice usual precautions.  To read the alert, please click the link http://www.cdc.gov/media/releases/2015/s0903-Liberia-travel.html.  

CDC Grand Rounds: Shifts in Global Health Security; Lessons from Ebola
In this session of Public Health Grand Rounds we discuss how CDC, other U.S. government agencies, and global partners are working to promote global health security as an international priority and accelerate progress toward a world safe and secure from epidemics of infectious disease.  View the September 29 session by going to http://www.cdc.gov/cdcgrandrounds/archives/2015/september292015.htm.

Gut Bacteria May Direct Immune Cell Attack in Eye Disorder
In autoimmune uveitis, the immune effector cells attacking proteins in the eye may be primed by the gut microbiota, according to findings from researchers from the National Eye Institute (NEI).  NEI researchers used mice predisposed to autoimmune uveitis and compared them in a germ-free environment and in a normal environment to compare rates of uveitis. See more at http://nih.gov/news/health/aug2015/nei-18.htm

CDC Modeling Projects Growth of Drug-Resistant Infections and C. difficile
The latest CDC Vital Signs shows the Center’s modeling projects of a coordinated approach in health care facilities and state health departments could prevent up to 70 percent of life threatening carbapenem-resistant Enterobacteriaceae (CRE) infections over the next five years.  To read more about the modeling as well at the projections on C. difficile, go to http://www.cdc.gov/media/releases/2015/p0804-hai-modeling.html

CDC Funding Helps States Address Infectious Disease Threats
On August 4, the Centers for Disease Control and Prevention (CDC) announced awards of nearly $110 million to help states and communities strengthen their capacity to track and respond to infectious diseases. The funding is allocated through the Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement (ELC), with a goal of helping states fight infectious disease outbreaks more quickly and develop better interventions to protect the public’s health.  See more about the programs funded by going to http://www.cdc.gov/media/releases/2015/p0803-cdc-funding.html.

MMWR Articles of Interest

Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Poliovirus Vaccine
On March 24, the Food and Drug Administration licensed an additional combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP) and inactivated poliovirus (IPV) vaccine (DTaP-IPV) (Quadracel, Sanofi Pasteur Inc.). Quadracel is the second DTaP-IPV vaccine to be licensed for use among children aged 4 through 6 years in the United States.  Read more about this formulation by reading http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6434a5.htm?s_cid=mm6434a5_w.

Large Outbreak of Botulism Associated with a Church Potluck Meal
A confirmed case of botulism was defined as clinically compatible illness in a person who ate food from a church potluck meal and had 1) laboratory-confirmed botulism or 2) two or more signs of botulism or one sign and two or more symptoms of botulism.

Use and Interpretation of a Rapid RSV Ag Detection Test among Infants Hospitalized in a NICU
On March 25, the Wisconsin Division of Public Health was notified of a possible respiratory syncytial virus (RSV) infection outbreak among infants hospitalized in a neonatal intensive care unit (NICU). A nasopharyngeal (NP) swab specimen collected from neonate A was tested using a single-manufacturer rapid RSV antigen detection test (RRADT) at the hospital laboratory; the result was positive. The following day, NP swab specimens from the remaining 16 asymptomatic NICU patients were tested using the same RRADT; seven tests were positive, making a total of 11 positives.  The same 20 nasopharyngeal specimens were sent to the Wisconsin State Laboratory of Hygiene for confirmatory testing using a multiplex respiratory virus real-time polymerase chain reaction (PCR) panel (eSensor, GenMark Diagnostics, Inc.) that targets 18 viruses, including RSV subgroups A and B.   To follow the results, see http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6431a6.htm?s_cid=mm6431a6_w.

OTHER INFORMATION AND UPDATES

IDWeek2015
San Diego, CA
October 7-11, 2015
Go to http://www.idweek.org/ to register.

ASCP 2015: Beyond the Lab
Long Beach, CA
October 28-30, 2015
See http://www.ascp.org/ascp2015 for information.

Articles of Interest

New Legionnaires’ Cases in Bronx Prompt Investigation
New York Times
September 28, 2015
Seven people in the Morris Park section of the Bronx have Legionnaires’ disease, spurring an investigation into the potential source of infection.  This cluster appears unrelated to the cluster of illness discovered in July and August of this year.

Drug and Biotech Industry Trade Groups Give Martin Shkreli the Boot
Washington Post
September 24, 2015
Both the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) disavowed the membership of Turing Pharmaceuticals in their trade groups.

Former Peanut Exec Gets 28 Years in Prison for Outbreak
Washington Post
September 22, 2015
A judge sentenced 61-year-old Stewart Parnell, the former Peanut Corporation of America owner, to 28 years in prison. It’s the harshest criminal penalty ever for a U.S. producer in a food-borne illness case and a span his attorneys say might as well be a life sentence.

In Key Anthrax Test, Scientist Just Threw out Test Tube Showing Sample Was Alive
USA Today
September 17, 2015
A critical test to ensure anthrax bacteria had been thoroughly killed so the samples could be safely shipped to researchers at other labs was thrown out by and Army scientist.  The records, released under the federal Freedom of Information Act (FOIA), reveal new details of how a scientist at the Army’s Dugway Proving Ground badly misjudged the effectiveness of one of the lab’s three kill procedures. 

CDC Hires Top Lab Safety Official to Address String of Incidents, Culture
USA Today
September 15, 2015
The Centers for Disease Control and Prevention announced that it has hired a permanent top official to oversee laboratory safety at the agency, more than a year after a string of its high-profile lab incidents with anthrax, Ebola and avian influenza started becoming public.  Stephan Monroe, who has been the CDC’s acting associate director for Laboratory Science and Safety since May, is being permanently appointed to the position.

New Surge of MERS Infections Hits Saudi Arabia
New York Times
August 20, 2015
Saudi Arabia is facing a new surge in cases of Middle East respiratory syndrome, a viral disease that has infected more than 1,100 people and killed more than 480 in the kingdom since it appeared in 2012.  The Saudi authorities shuttered the emergency ward of one of the kingdom’s largest hospitals after the appearance of 46 new cases there of MERS, the Saudi news media reported.

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