Friday, June 15
WS-01
Clinical Impact and Laboratory Detection of Newer β-Lactamases
1:00 p.m. - 4:30 p.m.
Esplanade Ballroom 304
Convener and Faculty:
Kenneth S. Thomson; Creighton Univ. Sch. of Med., Omaha, NE.
Description:
The focus will be on laboratory detection and clinical significance of ESBLs, AmpC β-lactamases, and carbapenemases and the issues and controversies these enzymes create. Issues addressed will include: Do I need to perform additional confirmatory tests? What interpretation provides the most accurate report – CLSI, FDA, or other? Is it necessary to edit or modify results? A variety of diagnostic methodologies and their limitations will be covered.
WS-03
Laboratory Operations During a Disaster: Are You Prepared?
1:00 p.m. - 4:30 p.m.
Esplanade Ballroom 302
Conveners and Faculty:
Thomas Williams; Methodist Hosp., Omaha, NE.
Gina Potenza; Great Expressions Dental Centers, Rochester MI
Description:
Emergency operations planning is foreign to laboratory professionals and healthcare, but is essential to promote our mission during disasters. This course will familiarize participants with the domestic structure and terminology of emergency planning, provide several potential scenarios which especially challenge laboratory disaster operations, and tour participants through the terms, tools, and steps used by professionals in EOP development and sustainment, following CLSI GP-36 (currently in development), for which the presenters serve as Chairholder and Vice Chairholder.
WS-04
Clinical Trials Microbiology: From Drug Discovery to Delivery
1:00 p.m. - 4:30 p.m.
Esplanade Ballroom 303
Convener:
Frank O. Wegerhoff; Covance Central Lab. Services, Indianapolis, IN
Judith Steenbergen; Cubist Pharmaceuticals, MA
Faculty:
Gregory Stone; Pfizer, Inc., Groton, CT
Judith Steenbergen; Cubist Pharmaceuticals, MA
Frank O. Wegerhoff; Covance Central Lab. Services, Indianapolis, IN
Mary R. Motyl; Merck & Co. Inc., Rahway, NJ
Description:
On completion of this workshop, participants will understand the entire clinical trials process from initial drug discovery to final market delivery. The focus of the workshop will be on how new drug compounds are discovered, early development, phases of clinical trials, the role of contract research organizations (CRO's) and the FDA, laboratory testing, and data management.
WS-05
The Gram-Stain: Making the Most of the Original Real-Time Multiplex Test
1:00 p.m. – 4:30 p.m.
Esplanade Ballroom 301
Convener and Faculty:
Steven Dallas; University of Texas Health Science Center, San Antonio, TX
Description:
In this age of molecular microbiology, the Gram stain is still an amazingly useful real time multiplex test. It is fast, inexpensive, can visualize multiple pathogens, and in the hands of an experienced microbiologist it can have direct impact on patient care in just a few minutes. However, meaningful results depend on five keys: the right specimen, appropriate application of the specimen to the slide, good staining, correct interpretation, and clear reporting. Using prestained glass slides and digital images, the participants will examine real patient cases in the context of these five keys and how each one affects the Gram stain result and how these results can affect patient care in a positive or negative way. Second, the presenter will use real life examples of dialog with clinicians that help turn unknowns into known so that patients are treated effectively. Lastly, the presenter will address ways to avoid common Gram stain errors and craft an effective Gram stain QA and review policy.
Saturday, June 16
WS-06
The BioCyc Collection of Pathway/Genome Databases
8:30 a.m. - 4:30 p.m.
Esplanade Ballroom 310
Convener:
Peter D. Karp; Bioinformatics Research Group, SRI Intl., Menlo Park, CA.
Faculty:
Peter D. Karp; Bioinformatics Research Group, SRI Intl., 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.
Room 232
Conveners:
Donna Wolk; Univ. of Arizona, Tucson, AZ.
Elizabeth M. Marlowe; Southern California Permanente Med. Group, North Hollywood, CA.
Faculty:
Donna Wolk; Univ. of Arizona, Tucson, AZ.
Elizabeth M. Marlowe; Southern California Permanente Med. Group, North Hollywood, CA.
Maurice M. Exner; Focus Diagnostics, Inc., Cypress, CA.
Melissa Miller; Univ. of North Carolina Sch. of Med., 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.
Esplanade Ballroom 302
Convener:
Christine C. Ginocchio; North Shore-LIJ Health System Lab., Lake Success, NY.
Faculty:
Christine C. Ginocchio; North Shore-LIJ Health System Lab., Lake Success, NY.
Angela Caliendo; Emory Univ. Hosp., Atlanta, GA.
Randall T. Hayden; St. Jude Children's Res. Hosp., 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.
Esplanade Ballroom 304
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 Lab., Chicago, IL.
Deborah L. Blecker-Shelly; The Children's Hosp. of Philadelphia, Philadelphia, PA.
Nancy S. Miller; Boston Med. Ctr., Boston, MA.
Beverley Orr; Boston Med. Ctr., 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.
Room 270
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.
Room 204
Conveners and Faculty:
Mario J. Marcon; Nationwide Children's Hosp., Columbus, OH.
Rangaraj Selvarangan; Children's Mercy Hosp. 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.
Esplanade Ballroom 306
Convener:
Robert J. Tibbetts; Henry Ford Health Sys., Detroit, MI.
Faculty:
Robert J. Tibbetts; Henry Ford Health Sys., Detroit, MI.
Alice S. Weissfeld; Microbiol. Specialists Inc., Houston, TX.
Mike Loeffelholz; Univ. of Texas Med. 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.
Esplanade Ballroom 308
Convener:
Donald C. Singer; GlaxoSmithKline, Collegeville, PA.
Faculty:
Anthony Cundell; Merck Res. Lab., 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.
Esplanade Ballroom 309
Convener:
Barbara Robinson-Dunn; William Beaumont Hosp., Royal Oak, MI.
Faculty:
Barbara Robinson-Dunn; William Beaumont Hosp., Royal Oak, MI.
Gerri S. Hall; Cleveland Clinic Fndn., Cleveland, OH.
Edward Desmond; California State Dept. of Publ. Health, Richmond, CA.
Description:
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.
Room 254
Convener:
Gary Procop; Cleveland Clinic, Cleveland, OH.
Faculty:
Gary Procop; Cleveland Clinic, Cleveland, OH.
Glenn D. Roberts; Mayo Clinic and Coll. of Med., 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.
Esplanade Ballroom 300
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 Hosp., Weill Cornell Med. Ctr., New York, NY.
Robert C. Jerris; Children's Healthcare of Atlanta, Atlanta, GA.
Audrey N. Schuetz; Weill Cornell Med. Coll., 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.
Esplanade Ballroom 301
Conveners:
Alexander Mellmann; Univ. of Münster, Münster, Germany
Dag Harmsen; Univ. of Münster, Münster, Germany
Faculty:
Alexander Mellmann; Univ. of Münster, Münster, Germany
Richard Goering; Creighton Univ. Sch. of Med., Omaha, NE
Stefan Niemann; Natl. Reference Ctr. Mycobacteria, Borset, Germany
Dag Harmsen; Univ. 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.
Esplanade Ballroom 303
Convener and Faculty:
Richard L. Hodinka; Children's Hosp. 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.
Esplanade Ballroom 305
Conveners:
Dag Harmsen; Univ. Münster, Münster, Germany.
Alexander Mellmann; Univ. of Münster, Münster, Germany.
Faculty:
Dag Harmsen; Univ. Münster, Münster, Germany.
Alexander Mellmann; Univ. 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.
