Clinical Microbiology Issues Update - December 2013

PSAB ACTIVITIES

  • Professional Affairs Committee Members Attend Reimbursement Seminars
  • ASM Attends CDC Board of Scientific Counselors Meeting
  • ASM Attends CCCLW Meeting
  • ASM Attends Joint CDC-AdvaMedDx Hill Briefing
  • ASM Participates in CDC Grand Rounds: Advanced Molecular Detection
  • ASM Participates in CDC Telebriefing on Serogroup B Meningococcal Cases in the United States
  • ASM Staff Meets with Senate HHS Staff
  • ASM Signs CLC Letter Requesting Negotiated Rulemaking
  • ASM Comments on CMS Proposed Proficiency Testing Referral Enforcement Flexibility
  • Minority Microbiology Mentor Newsletter

ASM NEWS, JOURNAL ARTICLES AND UPDATES

  • ASM Conferences
  • ASM Journal Articles of Interest
  • ASM Press

FEDERAL AGENCY UPDATES

  • Budget Deal Finalized by Congress
  • National Influenza Vaccination Week
  • World AIDS Day Commemorated
  • FDA Releases Guidance for In Vitro Diagnostic Products Labeled for RUO or IUO
  • FDA Approves First Adjuvanted Vaccine for Prevention of H5N1 Avian Influenza
  • Malaria Cases in U.S. Reach 40-year High
  • CDC Answers Meningitis Questions
  • Get Smart about Antibiotics Week
  • NIH Mouse Study Finds Gut Microorganisms May Determine Cancer Treatment Outcome
  • NIH Launches Trial of Investigational Genital Herpes Vaccine
  • FDA Allows Marketing of Four “Next Generation” Gene Sequencing Devices
  • FDA Investigates Outbreak of E. coli O157 Illnesses Linked to Pre-packaged Salad Products
  • MMWR Articles of Interest

OTHER INFORMATION AND UPDATES

  • Control of Foodborne and Waterborne Diseases Course: January 6–11, 2014
  • Waste Not Want Not: Tips and Tricks for Reducing Waste in the Clinical Lab
  • Articles of Interest

PSAB ACTIVITIES

Professional Affairs Committee Members Attend Reimbursement Seminars
The PSAB Professional Affairs Committee has been monitoring key developments in reimbursement for clinical laboratory tests. The final CMS rules “Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014 [CMS-1600]” https://www.federalregister.gov/articles/2013/12/10/2013-28696/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-clinical-laboratory and the “Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (OPPS) [CMS-1601]” http://www.gpo.gov/fdsys/pkg/FR-2013-12-10/pdf/2013-28737.pdf that were posted December 10 were subjects of webinars sponsored by G2 Intelligence and CodeMap® which PAC Chair Vickie Baselski and member Scott Riddell attended. CMS also still plans to implement its overhaul of the Clinical Laboratory Fee Schedule (CLFS) starting in 2014. The public will have a chance to comment on the proposed changes, and, after analysis, rates may be adjusted. As of CY 2014, CMS also plans to bundle clinical laboratory tests into the OPPS and will no longer pay separately for clinical laboratory services performed for hospital outpatients.

ASM Attends CDC Board of Scientific Counselors Meeting
ASM staff attended the December 11-12 meeting of the Board of Scientific Counselors, Office of Infectious Diseases. Topics for discussion on the first day included updates from the Influenza Coordination Unit (ICU), the National Center for Immunization and Respiratory Diseases (NCIRD), the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), the Center for Global Health (CGH) and Global Health Security (GHS). The second day’s discussion covered updates from the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) and updates on CDC’s Advanced Molecular Detection (AMD) for Infectious Disease Prevention and Response activities. PSAB Laboratory Practices Committee Chair Susie Sharp now co-chairs the AMD laboratory working group. For more information on the BSC OID, see http://www.cdc.gov/oid/BSC.html.

ASM Attends CCCLW Meeting
ASM staff attended the first Coordinating Council on the Clinical Laboratory Workforce (CCCLW) web conference meeting on December 9. PSAB Professional Affairs Committee Chair Vickie Baselski discussed current CMS proposals on CPT codes, as she serves as the chair of the CCCLW reimbursement subcommittee. Other topics included the Health Resources and Services Administration (HRSA) and the role of clinical laboratories, a new practitioner survey update, and the 2014 dues packet for CCCLW members. The next meeting will take place in March 2014. To read more about CCCLW, please go to the website http://ccclw.org/.

ASM Attends Joint CDC-AdvaMedDx Hill Briefing
On December 5, AdvaMedDx and the Centers for Disease Control and Prevention (CDC) cosponsored a briefing in the Rayburn House Office Building entitled “Innovative Technologies for Better Health: How Diagnostics are Accelerating Progress against HIV/AIDS: TB, Malaria and Emerging Infectious Diseases in the U.S. and Abroad”. This briefing focused on point of care testing and featured speakers Beth Bell, Director of the CDC National Center for Emerging and Zoonotic Infectious Diseases; Douglas Bryant, President and CEO of Quidel; John Hackett, Senior Research Fellow and Director of Diagnostic Infectious Diseases, Abbott; Tom Kenyon, Director of the CDC Center for Global Heath; and Todd Summers, senior advisor the Center for Strategic and International Studies (CSIS) Global Health Policy Center. To read more about the briefing, please go to http://advameddx.org and click “Events."

ASM Participates in CDC Grand Rounds: Advanced Molecular Detection
The Public Health Grand Rounds is a monthly webcast created to foster discussion on major public health issues. Each session focuses on key challenges related to a specific health topic, and explores cutting-edge scientific evidence and potential impact of different interventions by CDC and its partners. The December Grand Rounds explained the new CDC Advanced Molecular Detection Initiative to improve the ability to diagnose infectious diseases, investigate, and control outbreaks. To view, please click the following link http://www.cdc.gov/about/grand-rounds/archives/2013/december2013.htm.

ASM Participates in CDC Telebriefing on Serogroup B Meningococcal Cases in the United States
ASM Staff joined Amanda Cohn, National Center for Immunizations and Respiratory Diseases, in a November 25 CDC telebriefing to provide an update on serogroup B meningococcal cases in the United States and meningococcal disease treatment and prevention. The transcript is available at the following link http://www.cdc.gov/media/releases/2013/t1125-serogroup-b-meningitis.html.

ASM Staff Meets with Senate HHS Staff
ASM Staff joined members of the Coalition for Health Funding in a November 18 briefing with staff from the Senate Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee. Key staffers and their assignments for 2014 were introduced; most of the discussion that followed focused on the upcoming budget negotiations and how they may affect funding for healthcare related agencies.

ASM Signs CLC Letter Requesting Negotiated Rulemaking
ASM signed onto a November 12 letter with other members of the Clinical Laboratory Coalition urging the Congress to consider legislation requiring the Centers for Medicare and Medicaid Services (CMS) to enter into negotiated rulemaking with stakeholders to develop an updated clinical laboratory fee schedule. To see the full letter, please click the link: http://www.asm.org/images/PSAB/NegRule-2013.pdf.  

ASM Comments on CMS Proposed Proficiency Testing Referral Enforcement Flexibility
ASM provided comments to CMS regarding Changes to CLIA Enforcement Actions for Proficiency Testing (PT) Referral described in the Proposed Rule CMS-1443-P. This rule provides tiers of sanctions against laboratories referring PT samples. To see the letter, click http://www.asm.org/index.php/publicpolicy-2/statements-testimony/137-policy/documents/statements-and-testimony/92462-clia-11-13.

Minority Microbiology Mentor Newsletter
The December issue of the Minority Microbiology Newsletter has been published by the Committee on Microbiological Issues Impacting Minorities (CMIIM). ASM members 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/92686-mmm-12-13.

 

ASM NEWS, JOURNAL ARTICLES AND UPDATES

ASM Conferences

The ASM Biodefense and Emerging Diseases Research Meeting
January 27-29, 2014
Washington, DC

http://www.asmbiodefense.org/

4th ASM Conference on Enterococci
March 5-7, 2014
Cartagena, Colombia

12th ASM Conference on Candida and Candidiasis
March 26-30, 2014
New Orleans, Louisiana

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

ASM Journal Articles of Interest

Copious Community-Associated MRSA in Nursing Homes
More than one quarter of residents of 26 nursing homes in Orange County, California carry community-associated methicillin-resistant Staphylococcus aureus (MRSA), according to a manuscript published in the November 2013 issue of the Journal of Clinical Microbiology.

Irreproducible and Uninterpretable Polymyxin B MICs for E. cloacae and E. aerogenes
In this study involving clinical isolates, susceptibility testing methods with polymyxin B were analyzed. Due to heteroresistance, interpretation of polymyxin susceptibility tests for Enterobacter species should be undertaken with extreme caution.

Clinical Evaluation of BacT/Alert FA Plus and FN Plus Bottles Compared with Standard Bottles
Clinically significant bacteria, including Gram-negative bacilli, were isolated more frequently from the resin bottles than from the standard bottles. Clinically significant bacteria were detected faster using the aerobic resin bottles than using the standard aerobic bottles.

Evaluation of Pneumococcal Serotyping by Multiplex PCR and Quellung Reactions
Screening of 1,750 pneumococcal isolates for common serotypes by PCR was followed by Quellung reaction analysis of PCR-negative isolates with a comparison to the conventional approach. PCR agreed with Quellung reaction results for 99% of isolates. 

Interlaboratory Optimization and Evaluation of a Serological Assay for Diagnosis of Human Baylisascariasis
A Western blot assay using a recombinant protein, recombinant Baylisascaris procyonis RAG1 protein (rBpRAG1), was developed for the diagnosis of human baylisascariasis concurrently by the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, and the National Reference Centre for Parasitology (NRCP) in Montreal, Canada.  

ASM Press

Color Atlas of Medical Bacteriology, Second Edition
Authors: Luis de la Maza, Marie T. Pezzlo, Janet T. Shigei, Grace L. Tan, and Ellena M. Peterson
ASM member price: $139.95; Hardcover, 366 pages, color illustrations
(978-1-55581-475-5) for more information, please visit the e-store at:
http://www.asmscience.org/content/book/10.1128/9781555814755

FEDERAL AGENCY UPDATES

Budget Deal Finalized by Congress
The House and Senate have passed a budget compromise measure (HJ Res 59), which allocates to appropriations committees an increase in fiscal year 2014 spending levels and rolls back budgetary sequestration requirements that were due to impact research programs. Congressman Ryan and Senator Murray, chairs of a bipartisan and bicameral “Budget Conference Committee,” established by passage of the “Continuing Appropriations Resolution of 2014,” negotiated the “Bipartisan Budget Agreement Act of 2013 (BBA).” The agreement reconciles spending cap differences between the House and the Senate for FY 2014. The Ryan-Murray deal finalized discretionary spending for the current fiscal year (FY) 2014 at $1.012 trillion, roughly halfway between the House budget level of $967 billion and the Senate budget level of $1.058 trillion. The BBA also provides partial relief from sequestration in FY 2015. The agreement allows appropriators to draft spending bills for the remainder of FY 2014 and provides $63 billion in relief from sequester cuts over the next two years for both defense and non-defense discretionary programs.   The Bipartisan Budget Agreement is a step forward in mitigating some of the harm from the random cuts of sequestration. The ASM has been urging Congress to end sequestration and will continue to advocate for robust investment in basic research, public health and clinical lab policy as the appropriations process proceeds for FY 2014 and FY 2015. The Bipartisan Budget Act is designed to restore order to the federal budget and appropriations process and to allow some reinvestment in domestic priorities, such as research and public health. The BBA restores almost two-thirds of the scheduled non-defense discretionary cuts in 2014. House and Senate appropriations committees are beginning the process to write FY 2014 spending bills before the expiration of the current Continuing Resolution on January 15, 2014. Information and updates on appropriations bills will be available at http://www.asm.org/ResearchFunding.

National Influenza Vaccination Week
The U.S. Department of Health and Human Services, CDC, state and local health departments, and other health agencies observed National Influenza Vaccination Week December 8–14, 2013, with educational and promotional activities scheduled across the country. To read more, please go to http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6248a5.htm?s_cid=mm6248a5_w.

World AIDS Day Commemorated
World AIDS Day draws attention to the current status of the Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) epidemic worldwide. The theme for this year's December 1 observance was "Shared Responsibility: Strengthening Results for an AIDS-Free Generation." To read more, please go to http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6247a1.htm?s_cid=mm6247a1_w.

FDA Releases Guidance for In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only
On November 25, the U.S. Food and Drug Administration released “The Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only - Guidance for Industry and Food and Drug Administration Staff”. To see the final guidance document, please go to:  

FDA Approves First Adjuvanted Vaccine for Prevention of H5N1 Avian Influenza
The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus.

Malaria Cases in U.S. Reach 40-year High
In 2011, 1,925 malaria cases were reported in the United States, according to data published in a supplement of the Morbidity and Mortality Weekly Report (MMWR). This number is the highest since 1971. For more, see http://www.cdc.gov/media/releases/2013/p1031-malaria-cases.html.

CDC Answers Meningitis Questions
CDC answers questions on the recent outbreak at Princeton University and on serogroup B meningococcal vaccine. To read the answers to 27 pertinent questions, please go to http://www.cdc.gov/meningococcal/vaccine-serogroupB.html.

Get Smart about Antibiotics Week
Get Smart about Antibiotics Week was observed November 18-24. The video and presentation slides from the November session of CDC’s Public Health Grand Rounds, “Combating Resistance: Getting Smart about Antibiotics,” held on Tuesday, November 19 are now available at http://www.cdc.gov/about/grand-rounds/archives/2013/November2013.htm.

NIH Mouse Study Finds Gut Microorganisms May Determine Cancer Treatment Outcome
NCI scientists found that tumors of germ-free mice (mice completely lacking these microorganisms), or mice treated with antibiotics to deplete the gut of bacteria, were largely impaired in their ability to respond to immunotherapy that slows cancer growth and prolongs survival. To read more about this study, please go to: http://nih.gov/news/health/nov2013/nci-21.htm.

NIH Launches Trial of Investigational Genital Herpes Vaccine
Researchers have launched an early-stage clinical trial of an investigational vaccine designed to prevent genital herpes disease. The National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring the Phase I trial, which is being conducted at the NIH Clinical Center in Bethesda, MD. To read more, please click the link http://www.niaid.nih.gov/news/newsreleases/2013/Pages/HSV11-8-13.aspx.

FDA Allows Marketing of Four “Next Generation” Gene Sequencing Devices
On Nov 19, the U.S. Food and Drug Administration allowed marketing of four diagnostic devices that can be used for high throughput gene sequencing, often referred to as “next generation sequencing” (NGS). These instruments, reagents, and test systems allow labs to sequence a patient’s DNA. For more on the NGS, please see
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm375742.htm.

FDA Investigates Outbreak of E. coli O157 Illnesses Linked to Pre-packaged Salad Products
The FDA, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), the Centers for Disease Control and Prevention (CDC), and state and local officials are investigating a multi-state outbreak of E. coli O157:H7 illnesses possibly linked to prepackaged salad meals. Read the latest on this update by clicking http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm374327.htm.

MMWR Articles of Interest 

Extent and Effects of Recurrent Shortages of Purified-Protein Derivative Tuberculin Skin Test Antigen Solutions: United States, 2013
Two purified-protein derivative (PPD) tuberculin skin test (TST) antigen solutions are approved by the U.S. Food and Drug Administration (FDA): Tubersol (Sanofi Pasteur Ltd.) and Aplisol (JHP Pharmaceuticals, LLC). Tubersol was out of production in late 2012 through April 2013. Shortages of Aplisol resulted from increased demand as practitioners have sought a substitute for Tubersol. Tubersol production resumed in May 2013, and supplies had been nearly restored by early June. However, in mid-July, state tuberculosis (TB) control officials notified CDC of difficulty obtaining Tubersol and Aplisol.

Outbreaks of Human Metapneumovirus in Two Skilled Nursing Facilities: WV and ID, 2011–2012
During January and February 2012, state and local public health agencies in West Virginia and Idaho, with assistance from facility staff members and CDC, investigated outbreaks of unexplained respiratory illness characterized by high proportions of lower respiratory tract infections (LRTIs) at two skilled nursing facilities (SNFs). Influenza was initially suspected; however, human metapneumovirus (hMPV) was identified as the etiologic agent. 

Outbreak of Tuberculosis Associated with a Newly Identified Mycobacterium tuberculosis Genotype: NYC 2010–2013
In January 2010, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) identified a tuberculosis (TB) case caused by Mycobacterium tuberculosis with a genotype not reported previously in the United States. 

Primary Amebic Meningoencephalitis Associated with Ritual Nasal Rinsing: St. Thomas, U.S.V. I.
On November 21, 2012, the U.S. Virgin Islands (USVI) Department of Health documented the first case and death from primary amebic meningoencephalitis (PAM) in the territory. The patient was a man aged 47 years whose only reported freshwater exposures were the use of tap water for daily household activities and for ablution, a ritual cleansing that he practiced several times a day in preparation for Islamic prayer. 

Multistate Outbreak of C. jejuni Infections Associated with Undercooked Chicken Livers
In October 2012 the Vermont Department of Health (VDH) identified three cases of laboratory-confirmed Campylobacter jejuni infection in Vermont residents; the isolates had indistinguishable pulsed-field gel electrophoresis (PFGE) patterns.

Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children Now Online
The Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children are now available on the AIDSinfo website. These guidelines update the last version of the guidelines published in 2009. 

Salmonella Typhimurium Infections Associated with a Community College Microbiology Laboratory: Maine, 2013
In May 2013, multiple cases of salmonellosis were reported to the Maine Center for Disease Control and Prevention. Health and Environmental Testing Laboratory (HETL) determined that the clinical Salmonella isolates from stool specimens provided by outside hospital laboratories from both patients were indistinguishable by pulsed field gel electrophoresis (PFGE) analysis from a specimen used by the students during the microbiology class.

OTHER INFORMATION AND UPDATES

Control of Foodborne and Waterborne Diseases Course: January 6–11, 2014
CDC and Emory University's Rollins School of Public Health will cosponsor a 6-day course on Environmental Microbiology: Control of Foodborne and Waterborne Diseases at Emory University, Rollins School of Public Health. This course on the surveillance of foodborne and waterborne diseases is designed for public health practitioners and other students interested in the safety of food and water.

Waste Not Want Not: Tips and Tricks for Reducing Waste in the Clinical Lab
This program is part of the 2014 Seattle Children’s Hospital Series. These webinars are co-sponsored by AACC and Seattle Children’s Hospital, and conducted by Seattle Children’s Hospital. This particular webinar is designed to help participants identify and remove waste in the lab, simplify their systems, make fewer errors, and gain efficiencies.

Articles of Interest

Salmonella Outbreak Linked to Chicken Prompts Call for Action
USA Today
December 19, 2013
A national outbreak of antibiotic-resistant salmonella that's been ongoing since October has sickened more than 389 people in 23 states and is hospitalizing them at double the rate expected. In light of that, and recent tests finding high levels of salmonella in raw chicken nationally, a report issued Thursday by the Pew Charitable Trusts says that current policies don't protect public health and need to be changed.

CDC Issues Travel Health Advisory for St. Martin
Washington Post
December18, 2013
U.S. health authorities have issued a travel advisory for the French Caribbean dependency of St. Martin because of a mosquito-borne viral disease that is apparently being spread locally at the start of the winter tourist season. The U.S. Centers for Disease Control and Prevention said it is closely following reports of the Chikungunya virus among residents of the French side of the small island in the northeast Caribbean.

F.D.A. Restricts Antibiotics Use for Livestock
New York Times
December 11, 2013
The Food and Drug Administration put in place a major new policy to phase out the indiscriminate use of antibiotics in cows, pigs and chickens raised for meat, a practice that experts say has endangered human health by fueling the growing epidemic of antibiotic resistance.

Measles Cases in U.S. Rise; Most Unvaccinated, CDC Says
USA Today
December 5, 2013
The USA is experiencing a spike in measles, with 175 confirmed cases and 20 hospitalizations so far this year, according to the Centers for Disease Control and Prevention. More than 98% of measles patients were unvaccinated, CDC Director Frieden said.

Frederick Sanger, 95, Two-Time Winner of Nobel and Pioneer in Genetics, Dies
New York Times
November 21, 2013
Frederick Sanger, a British biochemist whose discoveries about the chemistry of life led to the decoding of the human genome and to the development of new drugs like human growth hormone, earning him two Nobel Prizes, a distinction held by only three other scientists, died on Tuesday in Cambridge, England.

Hospitals Try Yogurt to Prevent Infections in Patients
Wall Street Journal
November 17, 2013
At Holy Redeemer Hospital in Meadowbrook, PA, a worrisome trend emerged in 2011: an uptick in cases of C. difficile, despite measures to battle the bug by scrubbing surfaces with bleach and isolating affected patients. But the hospital was able to drive down cases last year after adding a new weapon to its arsenal: probiotics, the small organisms that help maintain the natural balance of bacteria in the intestines. 

Obama Selects Health Policy Advocate as Surgeon General
New York Times
November 14, 2013
President Obama nominated Dr. Vivek H. Murthy, as surgeon general on Thursday. Dr. Murthy, 36, is a founder and the president of Doctors for America and a physician at Brigham and Women’s Hospital in Boston and an instructor at Harvard Medical School.

Hepatitis C, a Silent Killer, Meets Its Match
New York Times
November 4, 2013
Medicine may be on the brink of an enormous public health achievement: turning the tide against hepatitis C, a silent plague that kills more Americans annually than AIDS and is the leading cause of liver transplants. If the effort succeeds, it will be an unusual conquest of a viral epidemic without using a vaccine.

 

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