Clinical Microbiology Issues Update - July 2015

PSAB ACTIVITIES

  • ASM Staff Attends DURC Stakeholder Engagement Workshop
  • ASM Asked to Submit Comments on the Framework for New NIH Strategic Plan
  • ASM Sends Comments to CMS on Laboratory Test Payment Rates
  • ASM and APHL Draft HIV Western Blot White Paper
  • ASM Staff Attends APUA Antibiotic Stewardship Seminar 
  • Former Professional Affairs Committee Chair Invited to Join CMS Laboratory Test Panel
  • TJC Laboratory PTAC Selects ASM Member Vice Chair
  • ASM Participates in White House Antibiotic Stewardship Forum
  • Minority Microbiology Mentor Newsletter

ASM NEWS, JOURNAL ARTICLES AND UPDATES

  • Clinical Microbiology Free Training
  • ASM Conferences
  • ASM Journal Articles of Interest
  • ASM Press
  • Articles of Interest
  • Course: Impact of New Microbiology Technology on Patient Outcomes

FEDERAL AGENCY UPDATES

  • FDA Approves Technivie for Treatment of Chronic Hepatitis C genotype 4
  • FDA Approves New Treatment for Chronic Hepatitis C genotype 3 Infections
  • FDA Food Safety Challenge Winners Develop Innovative Technologies to Detect Salmonella
  • FDA Approves Diagnostic Test to Differentiate between Types of HIV Infection
  • New CDC Study Highlights Burden of Pneumonia Hospitalizations among US Adults
  • Prevention and Early Treatment of RMSF in Arizona May Prevent Premature Death and Disability
  • NIAID-Funded Vaccine for West Nile Virus Enters Human Clinical Trials
  • MMWR Articles of Interest

OTHER INFORMATION AND UPDATES

  • World Hepatitis Day: July 28, 2015
  • First Meeting of the Commission on a Global Health Risk Framework for the Future
  • ASCP 2015: Beyond the Lab
  • Articles of Interest

 

PSAB ACTIVITIES

ASM Staff Attends DURC Stakeholder Engagement Workshop
On July 22, the White House Office of Science and Technology Policy (OSTP) and the National Institutes of Health co-hosted a public workshop for interested stakeholders to discuss implementation of the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC). The purpose of the all-day meeting was to inform and engage stakeholders, collect feedback about resources needed to implement policy, and discuss stakeholder experiences, challenges, and current practices.  For complete information about the workshop, please go to http://www.phe.gov/about/OPP/DURCworkshop/Pages/default.aspx.

ASM Asked to Submit Comments on the Framework for New NIH Strategic Plan
It is critical that ASM respond to NIH’s request for comments and we need input from members.  We urge you to send us your thoughts on the plan.  To see the plan and the instructions on where to direct your responses, please go to http://www.asm.org/index.php/public-policy/93-policy/93597-nih-sp.

ASM Sends Comments to CMS on Laboratory Test Payment Rates
The ASM presented recommendations to the Centers for Medicare & Medicaid Services at its annual public meeting on payment levels for new tests to be included in the 2016 Clinical Laboratory Fee Schedule. Only one code concerning infectious diseases was discussed.  For more information and to see the code in question, go to http://www.asm.org/index.php/public-policy/137-policy/documents/statements-and-testimony/93598-clfs-7-15.

ASM and APHL Draft HIV Western Blot White Paper
Members of the PSAB Laboratory Practices and Professional Affairs committees joined the Association of Public Health Laboratories (APHL) HIV and Viral Hepatitis Subcommittee to assist in preparation of “Limitations for the Use of HIV-1 Western Blot in Plasma/Serum.”  This document supports the discontinuation of HIV-1 Western blot testing in concert with the Centers for Disease Control and Prevention (CDC) and APHL’s newly published laboratory algorithm for HIV diagnosis, “Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations.”  See the ASM/APHL document at http://www.asm.org/images/PSAB/HIV-1-1-WesternBlotBrief.pdf for more details.   

ASM Staff Attends APUA Antibiotic Stewardship Seminar
The Alliance for the Prudent Use of Antibiotics (APUA) offered a webinar presented by Geraldine Hall entitled “Rapid Diagnostics in Clinical Microbiology as An Aid to Antibiotic Stewardship” on June 16, which ASM staff attended.  The APUA has been a leading global non-governmental organization working to preserve the effectiveness of antibiotics for nearly 35 years.  To read more about APUA and view the webinar materials, go to http://www.tufts.edu/med/apua/.

Former Professional Affairs Committee Chair Invited to Join CMS Laboratory Test Panel
Vickie Baselski, former Chair of the PSAB Professional Affairs committee, has been invited to serve on the Centers for Medicare and Medicaid (CMS) Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel).  The Panel was authorized by the Protecting Access to Medicare Act of 2014 (PAMA), and is charged with providing expertise related to clinical diagnostic tests.  One of the tasks the Panel will undertake is the establishment of payment rates for new clinical diagnostic laboratory tests.  Learn more about the panel by reading the Federal Register notice here http://www.gpo.gov/fdsys/pkg/FR-2014-10-27/pdf/2014-25401.pdf.

TJC Laboratory PTAC Selects ASM Member Vice Chair
PSAB Laboratory Practices Committee member Yvette McCarter has been selected Vice Chair of the Joint Commission’s (TJC) Laboratory Professional and Technical Advisory Committee (Lab PTAC) and represented the ASM on a June 23 conference call.  This committee is responsible for the development and refinement of standards and elements of performance in clinical laboratories.  The Joint Commission accredits and certifies more than 20,500 health care organizations and programs in the United States and PTACs are an integral part of TJC’s advisory structure.  To read more about Lab PTAC, go to http://www.jointcommission.org/accreditation/laboratory_ptac.aspx.     

ASM Participates in White House Antibiotic Stewardship Forum
On June 2, ASM joined more than 150 stakeholders to address the growing crisis of antimicrobial resistance at the White House Forum on Antibiotic Stewardship.  PSAB Biomedical Research Committee chair and Antibiotic Task Force Chair Gail Cassell represented ASM in this meeting.  To read all that ASM has been doing on antimicrobial resistance, go to http://www.asm.org/index.php/public-policy/92-news-room/press-releases/93541-asm-participates-in-white-house-antibiotic-stewardship-forum.  

Minority Microbiology Mentor Newsletter
The July 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: http://www.asm.org/index.php/public-policy-2/135-policy/documents/newsletters/minority-microbiology-mentor-newsletter/93578-mmm-7-15.

ASM NEWS, JOURNAL ARTICLES AND UPDATES

Clinical Microbiology Free Training
In a series of free webinars, COPAN teamed up with Dr. J. Michael Miller to provide educational videos to assist healthcare providers in collecting adequate and accurate patient specimen samples.  To see these videos and other free training webinars available, please go to https://clinmicro.asm.org/index.php/lab-management/training/432-free-training.  

ASM Conferences

ASM Conference on Pseudomonas 2015
September 8-12, 2015
Washington, DC

1st ASM Conference on Rapid Next-Generation Sequencing and Bioinformatic Pipelines for Enhanced Molecular Epidemiologic Investigation of Pathogens
September 24-27, 2015
Washington, DC

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

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

ASM Journal Articles of Interest

Researchers Identify New Class of Antifungal Agents
A June article in the open access online journal mBio® describes the identification identified a new class of antifungal agents.  The two agents identified target the synthesis of a fungal lipid called glucosylceramide (GlcCer) but does not interfere with the mammalian counterpart.  Read more at http://www.asm.org/index.php/journal-press-releases/93560-researchers-identify-new-class-of-antifungal-agents.

In Emergency Rooms, Female UTIs and STIs Misdiagnosed Nearly Half the Time
Urinary tract and sexually transmitted infections in women are misdiagnosed by emergency departments nearly half the time, according to a paper in the Journal of Clinical Microbiology.  These misdiagnoses result in overuse of antibiotics, and increased antibiotic resistance, according to Michelle Hecker from Case Western Reserve University and her collaborators.  Read more at http://www.asm.org/index.php/journal-press-releases/93564-in-ers-urinary-tract-and-sexually-transmitted-infections-in-women-misdiagnosed-even-mixed-up-nearly-half-the-time.

Universal Flu Vaccine in the Works
A new study shows that scientists may be able to create a ‘universal’ vaccine that can provide broad protection against numerous influenza strains, including those that could cause future pandemics.

In the new study, researchers used a virus-like particle vaccine cocktail that expressed a handful of different subtypes of a key surface protein of the influenza virus: H1, H3, H5 and H7.  Read more at http://www.asm.org/index.php/journal-press-releases/93595-universal-flu-vaccine-in-the-works.   

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.  

Antibodies for Infectious Diseases
Editors:  James E. Crowe, Diana Boraschi, Rino Rappuoli
Hardcover, 450 pages (est), full-color illustrations, index.
(ISBN: 9781555817350) For more information, please visit the e-store at: http://www.asmscience.org/content/book/10.1128/9781555817411.

Principles of Virology, Volume II: Pathogenesis & Control
Authors:  Jane Flint, Vincent R. Racaniello, Glenn F. Rall, Anna Marie Skalka
Paperback, 421 pages, full-color illustrations, index.
(9781555819347)  For more information, please visit the e-store at: http://www.asmscience.org/content/book/10.1128/9781555818968.

Articles of Interest

Variation in Outpatient Antibiotic Prescribing for Acute Respiratory Infections in the Veteran Population
Despite efforts to reduce antibiotic prescribing for acute respiratory infections (ARIs), information on factors that drive prescribing is limited.  The objective of this study was to examine trends in antibiotic prescribing in the Veterans Affairs population over an 8-year period and to identify patient, provider, and setting sources of variation.  See more at http://annals.org/article.aspx?articleid=2397690.

Spectrum of Enteropathogens Detected by the FilmArray GI Panel in Study of CA Gastroenteritis
The European, multicentre, quarterly point-prevalence study of community-acquired diarrhea (EUCODI) analyzed stool samples received at ten participating clinical microbiology laboratories (Austria, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Romania, and the UK) in 2014. Of the 709 samples received, 116 (16.4%) yielded multiple organisms. With the exception of Entamoeba histolytica and Vibrio cholerae, all of the 22 targeted pathogens were detected at least once. EPEC, Campylobacter species, toxigenic Clostridium difficile, EAEC, norovirus and ETEC were the six most commonly detected pathogens. This underlines the considerable potential of multiplex PCR to improve routine stool diagnostics in community-acquired diarrhea. Read more at http://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(15)00408-5/fulltext.  

Course: Impact of New Microbiology Technology on Patient Outcomes
As diagnostic microbiology laboratories evolve from profit to cost centers in the era of declining reimbursements, the clinical microbiologist will need a better understanding of how technology can impact the quality of patient care. In this course, the latest advances in technology for microbiology, some of the issues surrounding these methods, and the overall impact of these newer tests on patient care and health outcomes will be explored.  Each presentation is approved for one (1) P.A.C.E.® credit. Register at http://www.asm.org/index.php/professional-practice/124-whats-new/professional-development/93465-impact-of-new-microbiology-technology-on-patient-outcomes.  

FEDERAL AGENCY UPDATES

FDA Approves Technivie for Treatment of Chronic Hepatitis C genotype 4
On July 24, the FDA approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis).  Technivie in combination with ribavirin is the first drug that has demonstrated safety and efficacy to treat genotype 4 HCV infections without the need for co-administration of intereron. To learn more about Technivie, go to this website http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455857.htm.

FDA Approves New Treatment for Chronic Hepatitis C genotype 3 Infections
The U.S. Food and Drug Administration approved Daklinza (daclatasvir) on July 24 for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin.  Read more about Daklinza by going to this link http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm.

FDA Food Safety Challenge Winners Develop Innovative Technologies to Detect Salmonella
The U.S. Food and Drug Administration announced the winners of the 2014 FDA Food Safety Challenge, a prize competition to advance breakthrough ideas on how to find disease-causing organisms in food, especially Salmonella in fresh produce.  The Challenge was developed through the America COMPETES Reauthorization Act of 2010 and sought revolutionary improvements in the speed of the FDA’s detection methods for Salmonella.  Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455660.htm.

FDA Approves Diagnostic Test to Differentiate between Types of HIV Infection
The FDA approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first FDA-approved diagnostic that differentiates between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens. The BioPlex 2200 HIV Ag-Ab assay is intended for use with the BioPlex 2200 System, which was FDA cleared in 2004.  You can read more from this July 22 press release at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455813.htm.

New CDC Study Highlights Burden of Pneumonia Hospitalizations among US Adults
When U.S. adults are hospitalized with pneumonia, viruses are more often to blame than bacteria.  However, despite current diagnostic tests, neither viruses nor bacteria are detected in the majority of these patients according to a study by the Centers for Disease Control and Prevention (CDC) released in the New England Journal of Medicine.  See more at http://www.cdc.gov/media/releases/2015/p0714-pneumonia-hospitalizations.html.  

Prevention and Early Treatment of RMSF in Arizona May Prevent Premature Death and Disability
The mounting costs of an epidemic of Rocky Mountain spotted fever (RMSF) among Arizona American Indian populations suggest that prevention and control efforts would be cost effective.  A recent study released by experts at the CDC and the Indian Health Service (IHS), in partnership with Arizona tribes, describes an estimated $13.2 million in losses linked to the epidemic of RMSF between 2002 and 2011, on two Indian reservations.  Read more at http://www.cdc.gov/media/releases/2015/p0619-RMSF.html.

NIAID-Funded Vaccine for West Nile Virus Enters Human Clinical Trials
A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The experimental vaccine was discovered and developed by scientists at the Oregon National Primate Research Center at Oregon Health & Science University (OHSU) in Portland. 

To read more about the OHSU research team, led by senior scientist Mark Slifka and the investigational vaccine, HydroVax-001, go to http://www.niaid.nih.gov/news/newsreleases/2015/Pages/WNVtrials.aspx.  

MMWR Articles of Interest

Outbreak of Cryptosporidiosis among Veterinary Students Philadelphia, PA, February 2015
On February 20, 2015, a northeastern university's student health center was notified of five veterinary medicine students with gastrointestinal symptoms. An investigation was conducted to establish the existence of an outbreak, determine the etiology, evaluate risk factors, and recommend control measures.  All five students had attended a training session at the university's bovine obstetrics laboratory on February 13, which included the handling of two euthanized calves.

Serogroup B Meningococcal Disease Outbreak and Carriage Evaluation at a College: RI, 2015
On February 2, 2015, the Rhode Island Department of Health was notified of a case of meningococcal disease in a male undergraduate student at Providence College. Three days later, a second case was reported in a male undergraduate with no contact with the first student, indicating an attack rate of 44 cases per 100,000 students, nearly 500 times higher than the national incidence of 0.15 cases per 100,000 among persons aged 17–22 years.

Coccidioidomycosis in a State Where It Is Not Known To Be Endemic: MO, 2004-2013
During 1998‒2012, coccidioidomycosis cases increased nationally nearly eightfold. To describe the epidemiology of coccidioidomycosis in Missouri, a state without endemic coccidioidomycosis, surveillance data during 2004-13 at the Missouri Department of Health and Senior Services were retrospectively reviewed. The incidence of reported coccidioidomycosis increased from 0.05 per 100,000 in 2004 to 0.28 per 100,000 in 2013, with cases distributed throughout all regions of Missouri.

Measles Transmission in an International Airport at a Domestic Terminal Gate: April-May 2014
On April 22, 2014, the Minnesota Department of Health notified CDC of a case of measles in a child aged 19 months who had documentation of receiving 1 dose of measles, mumps, and rubella vaccine at age 12 months. The child's illness was clinically compatible with measles, which was confirmed by polymerase chain reaction and immunoglobulin M serology at the Minnesota Department of Health Public Health Laboratory. The child was febrile and developed a rash on April 17 while on an international flight from India to the United States before taking a connecting flight from Chicago to Minneapolis. Persons with measles are infectious from 4 days before to 4 days after rash onset.
 

OTHER INFORMATION AND UPDATES

World Hepatitis Day: July 28, 2015
July 28 marks the fifth annual World Hepatitis Day, established in 2010 by the World Health Organization to increase awareness and understanding of viral hepatitis. Millions of acute hepatitis infections occur each year, and approximately 400 million persons are living with chronic hepatitis B or hepatitis C. See http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6428a1.htm?s_cid=mm6428a1_w for information.

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

First Meeting of the Commission on a Global Health Risk Framework for the Future
The first meeting of the Commission on a Global Health Risk Framework for the Future took place July 28-29, 2015 at the National Academy of Sciences building, located Washington, DC. The first day was closed, but the meeting was open to the public on July 29.  The objectives of the open session on July 29 include an expert panel addressing issues of governance, finance, resilient health systems, and medical products research and development when responding to infectious disease outbreaks of international concern at the global, regional, national, and local levels. The Commission will consider the different perspectives presented, as they develop the approach for this study. To see the archived webcast, go to http://nam.edu/countering-threats-of-epidemic-infectious-diseases-first-meeting-of-the-commission-on-a-global-health-risk-framework-for-the-future/

Articles of Interest

Congress Questions Oversight of Biolab Safety at Hearing
USA Today
July 28, 2015
Federal laboratories working with bioterror pathogens are “the leading offenders” and have repeatedly been referred for sanctions because of serious safety violations, according to documents released at a hearing Tuesday on lab safety.

Bacteria are Many Things, but Selfish Isn’t One of Them, Scientists Say
Washington Post
July 23, 2015
A new study, published this week in Nature, says bacteria living in colonies are good at caring for their fellow microbes. Its authors say the life forms balance the opposing needs of individuals against the survival of the entire community by managing resources like space and food.

Liberia: Ebola Patients Discharged, Last of the Country’s Latest Wave
New York Times
July 20, 2015
The last four cases of Ebola in Liberia were discharged from a treatment clinic in the capital of Monrovia on July 20, meaning there were no more confirmed carriers of the deadly virus in the West African country.

Antibiotics Are Effective in Appendicitis, Study Says
New York Times
June 16, 2015
For more than 100 years, the standard treatment for appendicitis has been surgery. Now a large Finnish study provides the best evidence to date that most patients can be treated with antibiotics alone.

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