WORKSHOPS

WS-06
The BioCyc Collection of Pathway/Genome Databases

8:30 a.m. - 4:30 p.m.

Convener:
PETER D. KARP; Bioinformatics Research Group, SRI International., Menlo Park, CA.

Faculty:
PETER D. KARP; Bioinformatics Research Group, SRI International., Menlo Park, CA.
INGRID KESELER; SRI Intl., Menlo Park, CA.
RON CASPI; Bioinformatics Research Group, SRI Intl., Menlo Park, CA.

Description:
BioCyc is a collection of 1,100 genome databases available through the BioCyc.org website. This session will introduce microbiologists to the BioCyc website and to the version of BioCyc that can be installed on a scientist's computer. BioCyc provides scientists with facile access to a growing number of genomes and to a number of analytical software tools.

WS-07
Case Studies and Statistics for the Verification and Validations of Molecular Methods in the Clinical Laboratory

8:30 a.m. - 4:30 p.m.

Conveners:
DONNA WOLK; University of Arizona, Tucson, AZ.
ELIZABETH M. MARLOWE; Southern California Permanente Medical Group, North Hollywood, CA.

Faculty:
DONNA WOLK; University of Arizona, Tucson, AZ.
ELIZABETH M. MARLOWE; Southern California Permanente Medical Group, North Hollywood, CA.
MAURICE M. EXNER; Focus Diagnostics, Inc., Cypress, CA.
MELISSA MILLER; University of North Carolina School of Medicine, Chapel Hill, NC.

Description:
General guidelines for verification and validation of laboratory-developed tests (LDTs) are described in the current CLIA regulations for clinical laboratories, but they do not provide details of a concise “how to” scenario for new method verification and implementation. This workshop will describe CLIA and FDA requirements, as well as the CAP checklist items for verification of new tests in molecular microbiology. We will discuss basic biostatistics used in molecular laboratories and provide examples of experimental design and data analysis for qualitative, quantitative, and multiplex molecular methods.

WS-08
Update on Molecular Diagnostics for Clinical Virology

8:30 a.m. - 4:30 p.m.

Convener:
CHRISTINE C. GINOCCHIO; North Shore-LIJ Health System Laboratory, Lake Success, NY.

Faculty:
CHRISTINE C. GINOCCHIO; North Shore-LIJ Health System Laboratory, Lake Success, NY.
ANGELA CALIENDO; Emory University Hospital, Atlanta, GA.
RANDALL T. HAYDEN; St. Jude Children's Research Hospital, Memphis, TN.

Description:
This session will provide an update on the current molecular diagnostics techniques and assays (FDA cleared/approved, LDTs) available for the diagnosis of viral infections for the following syndromes: respiratory, CSF, enteric infections. In addition, specific lectures will address HPV and the new diagnostic tests recently approved by FDA, viral load monitoring for hepatitis B and C, HIV and transplantation (CVM, EBV, BK and JC). The advantages and limitations of each method/assay will be discussed, role of LDTs in the current regulatory environment, and what is currently needed and in development to increase diagnostic capabilities of all size laboratories.

WS-09
Administration in Clinical Microbiology: A Tool Kit for Supervisors and Managers

8:30 a.m. - 4:30 p.m.

Convener:
SUSAN HARRINGTON; Cleveland Clinic, Cleveland, OH.

Faculty:
NANCY E. CORNISH; Centers for Disease Control, Atlanta, GA.
NANCY ANDERSON; Centers for Disease Control, Atlanta, GA.
LINDA BRUNO; Alverno Clinical Laboratory, Chicago, IL.
DEBORAH L. BLECKER-SHELLY; The Children's Hospital of Philadelphia, Philadelphia, PA.
NANCY S. MILLER; Boston Medical Center, Boston, MA.
BEVERLEY ORR; Boston Medical Center, Boston, MA.

Description:
This workshop is designed to provide practical information for those involved in Microbiology Laboratory Administration. Properly managing the laboratory and doing so with efficiency takes knowledge and skill. The requirements of the government and regulatory agencies are complex and place great demands on laboratories that are often operating with limited resources. Topics to be addressed include proficiency testing, assessment of competency, laboratory inspections, quality assurance, planning and assessment for new tests, and test verification studies.

WS-10
Laboratory Diagnosis and Identification of Blood and Selected Tissue Parasites

8:30 a.m. - 4:30 p.m.

Conveners and Faculty:
LYNNE S. GARCIA; LSG & Associates, Santa Monica, CA.
GARY PROCOP; Cleveland Clinic, Cleveland, OH.

Description:
The program will provide updated information on diagnostic medical parasitology for blood and selected tissue parasites (STAT ordering, specimen collection, processing, testing, and reporting including recommended report comments). Key risk management issues regarding mishandling/misdiagnosis of these infections will be covered. Organism morphology, potential errors in diagnosis, pathogenesis, and clinical relevance will also be included for the five species of human malaria (Plasmodium vivax, P. ovale, P. falciparum, P. malariae, and P. knowlesi), as well as Babesia, Leishmania and Trypanosoma infections. Information related to blood parasite infections being seen in Afghanistan and Iraq will also be discussed, as will the spread of certain blood parasites within the United States. Technologists/microbiologists will be able to recognize these parasites in clinical specimens; identify common and less common parasites; and understand the uses and limitation of routine, molecular, serologic and antigen-based tests for the detection of infections caused by these parasites. Interactive case presentations will be strategically arranged to enhance learning and participation. A practical approach to testing will be emphasized. An extensive handout will be provided to each participant.

WS-11
Select Topics in Pediatric Clinical Microbiology

8:30 a.m. - 4:30 p.m.

Conveners and Faculty:
MARIO J. MARCON; Nationwide Children's Hospital, Columbus, OH.
RANGARAJ SELVARANGAN; Children's Mercy Hospital and Clinics, Kansas City, MO.

Description:
This workshop will review a number of topics relating to the laboratory diagnosis of infectious diseases of particular importance to pediatric patients. Topics to be reviewed will include streptococcal pharyngitis, pertussis, Mycoplasma pneumoniae infection, pneumococcal pneumonia, infectious mononucleosis and cervical lymphadenitis, microbiology of cystic fibrosis, influenza and RSV bronchiolitis, enteroviral/parechovirus meningitis and HSV encephalitis, infectious gastroenteritis including STEC disease, rotavirus and norovirus infection, C. difficile disease, STDs and sexual abuse in pediatrics, osteomyelitis and septic arthiritis, bacteremia and line sepsis. The workshop faculty will present diagnostic approaches used in their laboratories and solicit alternative approaches from the audience.

WS-12
Verification and Validation of Diagnostic Tests Used in the Clinical Microbiology Lab

8:30 a.m. - 4:30 p.m.

Convener:
ROBERT J. TIBBETTS; Henry Ford Health System, Detroit, MI.

Faculty:
ROBERT J. TIBBETTS; Henry Ford Health System, Detroit, MI.
ALICE S. WEISSFELD; Microbiology Specialists Inc., Houston, TX.
MIKE LOEFFELHOLZ; University of Texas Medical Branch, Galveston, TX.

Description:
Test verification and validation are required by CAP as part of a laboratories quality assurance plan; However, detailed guidance on when and how to perform these tests is sparse. Cumitech 31A is ASMs attempt to establish these guidelines to assist clinical microbiologists in wading through the different processes. For example, the verification requirements for unmodified, FDA cleared tests, modified (off label) commercial tests, and laboratory developed tests are quite different. At the end of this full day session, workshop participants will have an understanding of when test verification is needed and how to design a technically rigorous verification study that is compliant with laboratory regulations. In addition, they will gain an understanding of the essential components of test validation and continued quality assurance.

WS-13
Pharmaceutical Microbiology: Current Issues in Sterile Manufacturing and Product Development

8:30 a.m. - 4:30 p.m.

Convener:
DONALD C. SINGER; GlaxoSmithKline, Collegeville, PA.

Faculty:
ANTHONY CUNDELL; Merck Research Laboratory, Union, NJ.
DONALD C. SINGER; GlaxoSmithKline, Collegeville, PA.
JOHN LINDSAY; Aseptic Solutions, Inc., El Granada, CA.

Description:
New regulatory guidance, new technologies, and new paradigms have led to many insightful discussions and new practices for pharmaceutical microbiologists and their peers. From supply chain microbiology (excipient and component controls and testing) and formulation development, to manufacturing of sterile products and testing for their shelf-life, this workshop will offer knowledge and discussion on current key issues. Topics will include risk assessment, environmental controls (cleanrooms to isolators), container integrity testing, excipient and product testing. Faculty will share current views and respond to your specific concerns.

WS-14
2012 Clinical Mycobacteriology Update

8:30 a.m. - 4:30 p.m.

Convener:
BARBARA ROBINSON-DUNN; William Beaumont Hospital, Royal Oak, MI.

Faculty:
BARBARA ROBINSON-DUNN; William Beaumont Hospital, Royal Oak, MI.
GERRI S. HALL; Cleveland Clinic Foundation, Cleveland, OH.
EDWARD DESMOND; California State Department of Public Health, Richmond, CA.

The practice of clinical mycobacteriology is changing rapidly with guidelines for molecular detection of M. tuberculosis from clinical specimens and the detection of interferon gamma to supplement or replace PPD testing. Biochemical identification of isolates of Mycobacterium spp. is being replaced by molecular methods and mass spectrometry. This workshop will integrate conventional and molecular approaches for the detection and identification of Mycobacterium spp. Changes in taxonomy will be discussed as will new approaches to antimycobacterial susceptibility testing. Clinical cases will be used to highlight interesting issues. A discussion of Actinomycetes that are increasingly difficult to identify will be included.

WS-15
Laboratory Diagnosis of Fungal Infections: Identification of Filamentous Fungi

8:30 a.m. - 4:30 p.m.

Convener:
GARY PROCOP; Cleveland Clinic, Cleveland, OH.

Faculty:
GARY PROCOP; Cleveland Clinic, Cleveland, OH.
GLENN D. ROBERTS; Mayo Clinic and College of Medicine, Rochester, MN.

Description:
This workshop is designed to cover the aspects of clinical mycology associated with the identification of filamentous fungi (i.e. molds). It will begin with a basic differentiation of the various types of fungi, examine the identification characteristics of the most commonly encountered molds, and subsequently discuss a few of the less common molds. Technologists/microbiologists will be able to recognize these fungi in clinical specimens; identify common and less common filamentous fungi; and understand the uses and limitation of molecular, serologic and antigen-based tests for the detection of infections caused by these fungi. Important antifungal susceptibility testing will be discussed as appropriate. Interactive case presentations will be strategically arranged to enhance learning and participation; these will also illustrate the importance of selection of appropriate clinical specimens; use of appropriate laboratory testing and importance of communication between the laboratorian and physician. Participants will gain an appreciation for this discipline that has a direct impact on patient care.

WS-16
Problem Bugs, Resistant Drugs 2012

8:30 a.m. - 4:30 p.m.

Conveners:
STEPHEN M. BRECHER; VA Boston Healthcare System, West Roxbury, MA.
STEPHEN G. JENKINS; New York Presbyterian Hosp., Weill Cornell Med. Ctr., New York, NY.

Faculty:
STEPHEN M. BRECHER; VA Boston Healthcare System, West Roxbury, MA.
STEPHEN G. JENKINS; New York Presbyterian Hospital, Weill Cornell Medical Center, New York, NY.
ROBERT C. JERRIS; Children's Healthcare of Atlanta, Atlanta, GA.
AUDREY N. SCHUETZ; Weill Cornell Medical College., New York, NY.

Description:
This workshop will focus on some of the problem pathogens of 2012. Antibiotic Resistance issues will be focused on bacteria with initials (VISA, hVISA, and CREAPS (Carbapenemase-Resistant Enterobacteriaceae, Acinetobacter, Pseudomonas and Stenotrophomonas), whose testing is governed by agencies with initials (CLSI and the FDA). Detection issues will be focused on the rapidly improving test menus for Clostridium difficile and the changing epidemiological patterns of common bacterial respiratory pathogens. We will wrap it up with an overview of molecular tracking methods for epidemiological investigations.

WS-17
Molecular Typing of Bacterial Pathogens in 2012: Mining the Data and Interpreting the Results

8:30 a.m. - 4:30 p.m.

Conveners:
ALEXANDER MELLMANN; University of Münster, Münster, Germany
DAG HARMSEN; Univeristy of Münster, Münster, Germany

Faculty:
ALEXANDER MELLMANN; University of Münster, Münster, Germany
RICHARD GOERING; Creighton University School of Medicine, Omaha, NE
STEFAN NIEMANN; National Reference Center Mycobacteria, Borset, Germany
DAG HARMSEN; University of Münster, Münster, Germany

Description:
At the completion of this educational activity, participants will be able to understand and to apply various methods for molecular typing of bacteria. Focus of this workshop will be on current and future techniques, such as MLVA, MLST and next-gen sequencing and their pros and cons for different problems. Participants will be able to analyze and interpret generated typing data. Resources available for analysis and interpretation will be discussed. Demonstrations of selected resources will be presented.

WS-18
Modern Molecular Clinical Microbiology for Beginners

8:30 a.m. – 4:30 p.m.

Convener and Faculty:
RICHARD L. HODINKA; Children's Hospital of Philadelphia, Philadelphia, PA.

Description:
This workshop will review basic nucleic acid chemistries and molecular amplification technologies and discuss issues related to molecular diagnostic testing in a clinical microbiology laboratory. This workshop will also include a review of the available nucleic acid extraction, amplification, and detection methodologies. The workshop will conclude with discussions of clinical utility, method validation/verification, quality control/quality assurance issues, and the newest technologies and equipment. This workshop is designed to be interactive and attendees are encouraged to ask questions and present problems for discussion.

WS-19
Trends in Clinical Laboratory Identification of Microbes in 2012: MALDI ToF MS

8:30 a.m. – 4:30 p.m.

Conveners:
DAG HARMSEN; University Münster, Münster, Germany.
ALEXANDER MELLMANN; University of Münster, Münster, Germany.

Faculty:
DAG HARMSEN; University Münster, Münster, Germany.
ALEXANDER MELLMANN; University of Münster, Münster, Germany.
ROBIN PATEL; Mayo Clinic, Rochester, MN.

Description:
In 2010 a CPT code was finally introduced for reimbursement of DNA sequence based identification of microbes. Using matrix-assisted laser desorption ionization time of flight (MALDI ToF) mass spectrometry for identification of microbes is an emerging technology in clinical laboratories that is rapid and requires nearly no consumables. - At the completion of this educational activity, participants will be able to apply methods for DNA sequence and MALDI TOF mass spectrometry based identification of microbes. Participants will be able to analyze and interpret generated data. Attendees will know how to apply QC/QA measures related to DNA sequence (including CLSI MM18 guideline) and MALDI TOF based identification of bacteria. It is intended to have - if logistical possible - a live demonstration of MALDI ToF bacterial identification.

SYMPOSIA

Special Interest Session
Microbiology Career Choices: Learn What's Available and How to Succeed

1:00 p.m. – 4:30 p.m.

Developed by the Education Board

Convener:
NEIL BAKER; The Ohio State University, Columbus, OH

Invited Speakers:
Microbiologists representing the diversity of careers from entry through top level positions in industry, government, higher education, public policy and more.

Description:
Take control of your future! Identify a career that suits your personality, interest, and needs. In this special interest session, participants will first hear from a short list of microbiologists from diverse careers in microbiology. Following these short presentations, the audience will interact with career advisers in small group discussions. Potential career advisers may come from and describe the work, culture, and people

• In a clinical laboratory

• As a public health worker in the field

• In sales, marketing or business development inside a company,

• On a research team in a big pharma or agri business

• In a high security, defense agency

• As a teacher of high school or community college students

• On the frontlines reporting science news

• In the halls of government affecting science policy

OPENING SESSION

Opening Session

5:00 p.m. – 7:00 p.m.

Conveners:
MARGARET MCFALL-NGAI; University of Wisconsin-Madison, Madison, WI
ARTURO CASADEVALL; Albert Einstein College of Medicine, Bronx, NY
DAVID C. HOOPER; Massachusetts General Hospital, Boston, MA

Invited Speakers:

Biology by Design: The Emergence of Synthetic Biology
JAMES COLLINS; Center for BioDynamics, Boston, MA ASM Lecturer

Inherited Wolbachia Infections of Insects and a Potential Role in Reducing the Transmission of Dengue
SCOTT O’NEILL; Monash University, Melbourne, Australia

Iron Oxides to Infections: Linking Geo- and Medical Microbiology
DIANNE NEWMAN; California Institute of Technology, Pasadena, CA From