Clinical Microbiology Issues Update - April 2015

PSAB ACTIVITIES

  • Lab Practices Prepares Endoscopy Document
  • ASM Celebrates Medical Laboratory Professionals Week
  • ASM Sends Letter Addressing CDC Biosafety Recommendations
  • ASM Comments on Select Agent Changes
  • ASM Submits Appropriations Recommendations
  • Minority Microbiology Mentor Newsletter

ASM NEWS, JOURNAL ARTICLES AND UPDATES

  • April Clinical Microbiology Portal Hot Topic
  • Clinical Microbiology Portal Q & A
  • ASM Conferences
  • ASM Journal Articles of Interest
  • ASM Press
  • Articles of Interest

FEDERAL AGENCY UPDATES

  • FDA and CMS Form Task Force on LDT Quality Requirements
  • Ebola Vaccine Trial Begins in Sierra Leone
  • CDC Microneedle Patch for Measles Vaccination Could Be a Game Changer
  • CDC Develops Interim Culture Method for the Duodenoscopes
  • FDA Approves New Antifungal Drug Cresemba
  • FDA Approves Treatment for Inhalation Anthrax
  • MMWR Articles of Interest

OTHER INFORMATION AND UPDATES

  • Institute of Medicine to Become National Academy of Medicine
  • Diagnostic Test Working Group Proposes Alternative to FDA’s LDT Framework
  • WHO World Immunization Week
  • World Malaria Day: April 25, 2015
  • Webinar: Utilization Management in Medical Microbiology
  • ASCP 2015: Beyond the Lab
  • Articles of Interest

PSAB ACTIVITIES

Lab Practices Prepares Endoscopy Document
The PSAB Committee on Laboratory Practices prepared a document titled On the Question of Culturing of Duodenoscopes to address the unique challenges of pathogen identification in cases of infections associated with gastrointestinal endoscopy. You can find the document by going to: http://www.asm.org/index.php/public-policy-2/98-policy/issues/93456-lp-4-15

ASM Celebrates Medical Laboratory Professionals Week
ASM supports Medical Laboratory Professionals Week (MLPW) April 19-25, 2015 and saluted the more than 300,000 medical laboratory professionals around the country who perform and interpret more than 10 billion laboratory tests in the United States each year.  To read more, go to: http://www.asm.org/index.php/public-policy-2/98-policy/issues/1568-labweek.     

ASM Sends Letter Addressing CDC Biosafety Recommendations
The ASM sent a letter to Sylvia Mathews Burwell, Secretary of Health and Human Services regarding the document “Recommendations of the Advisory Committee to the Director Concerning Laboratory Safety at CDC”.  The letter and the recommendations can be found at http://www.asm.org/index.php/public-policy-2/137-policy/documents/statements-and-testimony/93431-cdc-5-15.   

ASM Comments on Select Agent Changes
In April, the ASM commented on the CDC proposed modifications to the list of Select Agents and Toxins.  While agreeing with the reasons for removing them from the Select Agents list, it is important to remember that these organisms must still be handled using high quality safety precautions.  To read the comments, see http://www.asm.org/index.php/public-policy/137-policy/documents/statements-and-testimony/93447-sar-4-15.    

ASM Submits Appropriations Recommendations
The ASM submitted FY 2016 appropriations recommendations to the House and Senate Appropriations Committees for research and public health programs supported by certain federal agencies.  You can see more by going to http://www.asm.org/index.php/public-policy-2/137-policy/documents/statements-and-testimony/93425-fy-2016.  

Minority Microbiology Mentor Newsletter
The April issue of the Minority Microbiology Newsletter has 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/93462-mmm-4-15.

ASM NEWS, JOURNAL ARTICLES AND UPDATES

April Clinical Microbiology Portal Hot Topic
The April Hot Topic discussion Verification of Non-FDA Approved Tests” was presented by Michael Loeffelholz, Ph.D., D(ABMM), University of Texas Medical Branch, Galveston. The discussion can be found by going to http://clinmicro.asm.org/index.php/portal/hot-topics/82-portal-resources/447-verification-of-non-fda-approved-tests.

Clinical Microbiology Portal Q & A
ASM members can submit questions to the Clinical Microbiology Portal for an expert's response and search an existing database of questions that have already been answered.  To see these, go to https://clinmicro.asm.org/index.php/component/content/article?id=417:question-and-answer.

ASM Conferences

4th ASM Conference on Antimicrobial Resistance in Zoonotic Bacteria and Foodborne Pathogens
May 8-11, 2015
Washington, DC

5th ASM Conference on Prokaryotic Cell Biology and Development
June 12-16, 2015
Washington, DC

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

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

ASM Journal Articles of Interest

Consolidated Clinical Microbiology Laboratories
Reimbursement of laboratory tests in the United States has resulted in significant consolidation of clinical laboratory facilities. This has resulted in the development of centralized clinical microbiology laboratories that provide services to patients receiving care in off-site locations.  This article provides thorough discussion of time-sensitive issues pertinent to clinical microbiology.  Read more at http://jcm.asm.org/content/53/5/1467.full

A Novel Technique for Detecting Antibiotic-Resistant Typhoid from Rapid Diagnostic Tests
An antigen-detecting rapid diagnotic test (RDTs) can rapidly diagnose typhoid from blood cultures. A simple, inexpensive molecular technique performed with DNA from positive RDTs accurately identified gyrA mutations consistent with fluoroquinolone-resistance.  To read the full journal article, please go to http://jcm.asm.org/content/53/5/1758.full.

Methicillin-Resistant Staphylococcus aureus Adaptation to Human Keratinocytes
From a collection of S. aureus isolated from chronically infected patients with atopic dermatitis, an agr mutant-like phenotype was noted. Using several models of human skin infection, authors demonstrate that toxin-deficient, agr mutants of MRSA are able to persist within keratinocytes.  This article can be found at http://mbio.asm.org/content/6/2/e00289-15.

Genetically Engineered Salmonella Promising as Anti-cancer Therapy
A new study has demonstrated that genetically modified Salmonella can be used to kill cancer cells. The study is published in the April 14 issue of mBio®. According to Roy Curtiss III, from Arizona State University, who was involved with the research, there has long been interest in using genetically engineered microbes to target and destroy solid tumors.  To read more, go to https://www.asm.org/index.php/asm-newsroom2/press-releases/92-news-room/press-releases/93460-genetically-engineered-salmonella-promising-as-anti-cancer-therapy.

First Case of Rabies since 2003: Lessons for Healthcare Personnel
A team of French clinicians has diagnosed the first case of rabies in France since 2003. Only 20 cases of human rabies had been diagnosed in France between 1970 and 2003. The patient was unaware of having been bitten, so the diagnosis was not suggested until day 12 post admission to the intensive care unit. The case report appeared April 8 in the Journal of Clinical Microbiology.  Read more at https://www.asm.org/index.php/asm-newsroom2/press-releases/92-news-room/press-releases/93471-first-case-of-rabies-in-over-a-decade-lessons-for-healthcare-personnel.

Can Humans Get Norovirus From Their Dogs?
Human norovirus may infect our canine companions, according to research published online April 1 in the Journal of Clinical Microbiology.  That raises the possibility of dog-to-human transmission, said author Sarah Caddy, a veterinarian and graduate student at the University of Cambridge, and Imperial College, London. Norovirus is the leading cause of food-borne illness in the United States. To read more, please see https://www.asm.org/index.php/journal-press-releases/93458-can-humans-get-norovirus-from-their-dogs.    

ASM Press

Antibodies for Infectious Diseases
Editors:  James E. Crowe, Jr., Diana Boraschi, and Rino Rappuoli
Hardcover, 600 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.

Enterohemorrhagic Escherichia coli and Other Shiga Toxin-Producing E. coli
Editors:  Vanessa Sperandio and Carolyn J. Hovde
Hardcover, 550 pages (est), full-color illustrations, index.
(ISBN: 9781555818784) For more information, please visit the e-store at: http://www.asmscience.org/content/book/10.1128/9781555818791.

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/10.1128/9781555818722.

Articles of Interest

Bacteria Bonanza Found in Remote Amazon Village
An isolated group of Native Amerindians in the Venezuelan Amazon hosts the most-diverse collection of microbes discovered in humans, researchers reported on 17 April in Science Advances. The group's microbiome includes bacteria with genes that confer antibiotic resistance, even though its members, part of the Yanomami, are not thought to have been exposed to antibiotics.

Reappearance of Chikungunya, Formerly Called Dengue, in the Americas
After an absence of about 200 years, chikungunya returned to the American tropics in 2013. The virus is maintained in a complex African zoonotic cycle but escapes into an urban cycle at 40- to 50-year intervals, causing global pandemics.

FEDERAL AGENCY UPDATES

FDA and CMS Form Task Force on LDT Quality Requirements
Under FDA’s proposed framework for the oversight of laboratory developed tests (LDTs), FDA would oversee the quality of these laboratory tests, alongside the Centers for Medicare and Medicaid Services (CMS), which regulate the laboratories themselves through the Clinical Laboratory Improvement Amendments (CLIA). To coordinate efforts, FDA and CMS are establishing an interagency task force that will continue and expand a collaboration related to the oversight of LDTs. The task force will work to address a range of issues, including those involving quality requirements for LDTs.  Read about this collaboration at http://blogs.fda.gov/fdavoice/index.php/2015/04/fda-and-cms-form-task-force-on-ldt-quality-requirements/.  

Ebola Vaccine Trial Begins in Sierra Leone
The Centers for Disease Control and Prevention, in partnership with the Sierra Leone College of Medicine and Allied Health Sciences and the Sierra Leone Ministry of Health and Sanitation, is now enrolling and vaccinating volunteers for the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). This study will assess the safety and efficacy of the rVSV-ZEBOV candidate Ebola vaccine among health and other frontline workers.  Details about the trial are here http://www.cdc.gov/media/releases/2015/p0414-ebola-vaccine.html

CDC Microneedle Patch for Measles Vaccination Could Be a Game Changer
A new microneedle patch being developed by the Georgia Institute of Technology and the Centers for Disease Control and Prevention could make it easier to vaccinate people against measles and other vaccine-preventable diseases.  The microneedle patch is designed to be administered by minimally trained workers and to simplify storage, distribution, and disposal.  See the device at http://www.cdc.gov/media/releases/2015/p0427-microneedle-patch.html.

CDC Develops Interim Culture Method for the Duodenoscopes
The Centers for Disease Control and Prevention have developed “an Interim Culture Method for the Duodenoscope” to culture bacteria from reprocessed duodenoscopes (after drying) specifically from the distal end and instrument channel.  There was very limited information to guide the use of cultures to assess reprocessing prior to this document; and recent outbreaks have made it necessary. The protocol can be found here http://www.cdc.gov/hai/settings/lab/lab-duodenoscope-culture-method.html.

FDA Approves New Antifungal Drug Cresemba
In March, U.S. Food and Drug Administration approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437106.htm.

FDA Approves Treatment for Inhalation Anthrax
The U.S. Food and Drug Administration approved Anthrasil, Anthrax Immune Globulin Intravenous, to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.  See more on Anthracil at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm439752.htm.

MMWR Articles of Interest

Measles: United States, January- April 2, 2015
As a result of high 2-dose measles vaccination coverage in the United States and improved control of measles, the United States declared measles eliminated in 2000. Importations from other countries where measles remains endemic continue to occur, however, which can lead to clusters of measles cases in the United States. To update surveillance data on current measles outbreaks, CDC analyzed cases reported during January 4 through April 2, 2015. A total of 159 cases were reported during this period. Over 80% of the cases occurred among persons who were unvaccinated or had unknown vaccination status.

Importation and Domestic Transmission of Shigella sonnei Resistant to Ciprofloxacin
In December 2014, PulseNet, the national molecular subtyping network for foodborne disease, detected a multistate cluster of Shigella sonnei infections with an uncommon pulsed-field gel electrophoresis (PFGE) pattern. CDC's National Antimicrobial Resistance Monitoring System (NARMS) laboratory determined that isolates from this cluster were resistant to ciprofloxacin, the antimicrobial medication recommended to treat adults with shigellosis.

Campylobacteriosis Outbreak Associated with Consuming Undercooked Chicken Liver Pâté
In January 2014, the Ohio Department of Health notified the Oregon Public Health Division (OPHD) of campylobacteriosis in two Ohio residents recently returned from Oregon. The travelers reported consuming chicken liver pâté at an Oregon restaurant. Campylobacter jejuni was isolated in cultures of fecal specimens from three patients.

Sustained Decrease in Laboratory Detection of Rotavirus after Implementation of Routine Vaccination
Before the introduction of rotavirus vaccine in the United States in 2006, rotavirus infection caused significant morbidity among U.S. children, with an estimated 55,000–70,000 hospitalizations and 410,000 clinic visits annually. National declines in rotavirus detection were noted, ranging from 57.8%–89.9% in each of the 7 post-vaccine years compared with all 7 pre-vaccine years combined.

Mycoplasma pneumoniae Outbreak in a Long-Term Care Facility; Nebraska, 2014
In June 2014, a Nebraska long-term care facility notified the East Central District Health Department (ECDHD) and Nebraska Department of Health and Human Services (NDHHS) of an outbreak of respiratory illness characterized by cough and fever in 22 residents and resulting in four deaths during the preceding 2 weeks. To determine the etiologic agent, Nebraska and CDC investigators collected nasopharyngeal (NP) and oropharyngeal (OP) swabs or autopsy specimens from patients for real-time polymerase chain reaction (PCR) testing at CDC.

OTHER INFORMATION AND UPDATES

Institute of Medicine to Become National Academy of Medicine
On April 28, at its 152nd annual meeting, the membership of the National Academy of Sciences voted to change the name of the Institute of Medicine to the National Academy of Medicine. The newly named National Academy of Medicine will continue to be an honorific society and will inherit the more than 1,900 current elected members and foreign associates of the IOM.  Read the announcement at http://www.iom.edu/Global/News%20Announcements/IOM-to-become-NAM-Press-Release.aspx.  

Diagnostic Test Working Group Proposes Alternative to FDA’s LDT Framework
The Diagnostic Test Working Group (DTWG), an independent group consisting of representatives from diagnostic manufacturers and clinical laboratories, released an alternative to FDA’s LDT Framework.  For labs, the alternative would mean greater regulation of LDTs while not trying to fit LDTs into the traditional medical device regulatory framework.  For the whole blog post, please see http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/04/diagnostic-test-working-group-proposes-alternative-to-fdas-ldt-framework.html.

WHO World Immunization Week
The World Immunization Week, April 24-30, 2015, will signal a renewed global, regional, and national effort to accelerate action to increase awareness and demand for immunization by communities, and improve vaccination delivery services. Read more at http://www.who.int/campaigns/immunization-week/2015/en/.

World Malaria Day: April 25, 2015
World Malaria Day was commemorated on April 25, the date in 2000 when 44 African leaders met in Abuja, Nigeria, and committed their countries to reducing malaria-related deaths.  For more information, see http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6415a8.htm?s_cid=mm6415a8_w.

Webinar: Utilization Management in Medical Microbiology
Join AACC for this 60-minute webinar and learn how one organization manages test utilization in today’s dynamic microbiology testing environment.

SPEAKER: John Branda, MD, Assist. Pathologist and Assoc. Director, Microbiology Laboratory, Mass. General Hospital

Read more at https://www.aacc.org/store/webinars/9700/utilization-management-in-medical-microbiology.

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

Articles of Interest

Tyson: Nix Human Antibiotics in Chickens by 2017
USA Today
April 28, 2015
Tyson Foods, the nation's biggest chicken processor rocked the poultry world when it announced that it plans to eliminate use of human antibiotics with its U.S. broiler chicken flocks by fall of 2017.

Scientists are Skeptical about the Secret Blood Test that has made Elizabeth Holmes a Billionaire
Business Insider
April 25, 2015
Theranos, a company founded by Elizabeth Holmes in the fall of 2003 has generated a lot of buzz for developing a revolutionary approach to the blood test.  Theranos' innovation theoretically does clinical lab testing faster, cheaper, and, in some ways, better. But the more buzz Theranos gets, the more questions people seem to have.

Another Study Shows No Link between MMR Vaccine and Autism
Wall Street Journal
April 21, 2015
On the heels of a measles outbreak in California fueled by vaccination fears that scientists call unfounded, another large study has shown no link between the measles-mumps-rubella vaccine and autism.

Ebola Researchers Take New Look at Risk of Sexual Transmission
New York Times
April 16, 2015
Concerned about the potential for sexual transmission of Ebola, international health officials are investigating new reports of suspected cases and beginning studies to determine how often and how long the virus remains active in semen. And, for now, they are warning survivors to practice protected sex indefinitely.

Reports to Feds on Deadly Bacteria Outbreaks Arrived Late
USA Today
April 15, 2015
Reports alerting federal officials that contaminated medical scopes appeared to be spreading deadly superbugs among hospital patients sometimes arrived months late, or not at all, according to federal records and interviews.

TPL_asm2013_SEARCH

93494:cmiu-4-15