CLSI Directors Installed at Leadership Conference, Baltimore, 17 March 2005
Susan Blonshine, RRT, RPFT, AE-C, FAARC. President of TechEd Consultants, Inc., enters her second term as a CLSI Board member. With extensive research experience, Ms. Blonshine is cited in dozens of medical journals, has presented at many professional conferences and meetings, and has developed several multimedia training references. Ms. Blonshine is a member of the U.S. Technical Advisory Group, ISO/TC 212, and a member and active committee participant of the American Association for Respiratory Care.
For full press release.
Maria Carballo. Ms. Carballo is Section Head of the Medical Devices Bureau, Device Evaluation Division – In Vitro Diagnostic Devices (IVDD) Section at Health Canada in Ottowa. With extensive research and clinical experience in the field of sexually transmitted diseases, for over 15 years, Ms. Carballo has held various positions at Health Canada, Ottawa, Ontario. She is also an active participant in the Global Harmonization Task Force Study Group 1 to develop documents promoting harmonization of regulatory requirements for IVDDs.
For full press release.
Russel Enns, PhD. Senior Vice President, Regulatory and Clinical Affairs, Quality System and Reimbursement at Cepheid in Sunnyvale, CA, Dr. Enns and his team headed the successful clearance and approval of the first six out of seven human genetic tests in the U.S. while an employee of Vysis. He has also previously served as Vice President of Technical Affairs at MicroProbe Corporation (1992-5), where he and his team achieved the first and only successful FDA clearance of a multiplex DNA probe test for physician office use.
For full press release.
Lillian J. Gill, DPA. Senior Associate Director of the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), Dr. Gill provides leadership and program direction for radiological health, science, and compliance / enforcement issues. She has previously held positions as Director, Office of Compliance, CDRH; and Deputy Director and Acting Office Director, Office of Science and Technology, CDRH.
For full press release.
Jeannie Miller, RN, MPH. Director of the Division of Institutional Quality Standards, Clinical Standards Group, Office of Clinical Standards and Quality at the Centers for Medicare and Medicaid Services, Ms. Miller is responsible for establishing clinical quality and safety standards for participating inpatient healthcare organizations in the Medicare and Medicaid program. In addition to her participation in CLSI, Ms. Miller is a member of the Joint Commission on Accreditation of Health Care Organizations’ Hospital Professional Technical Advisory Committee and credentialing expert panel, as well as a member of the National Practitioner Data Bank Executive Committee.
For full press release.
James Thomas. ASTM International President James Thomas has served in various positions at ASTM since 1972. In 1983 he was promoted to Vice-President of the Standards Development Division, and became President of ASTM in 1992. Mr. Thomas also serves on the Board of Directors of the American National Standards Institute, and is a member of the Standards Engineering Society, the Council for Engineering and Scientific Society Executives, the American Society for Association Executives, and the Industry Functional Advisory Committee on Standards for Trade Policy Matters.
For full press release.
Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) Provides Current Standards for Resistance Testing (M100-S15)
CLSI has recently published the well-known antimicrobial susceptibility testing standard, Performance Standards for Antimicrobial Susceptibility Testing: Fifteenth Informational Supplement (M100-S15), providing the latest recommendations for detecting emerging resistance. The recommendations and latest QC ranges provided in CLSI documents for detecting resistance are followed by manufacturers in the development of panels and software. In addition, the documents outline valuable and timely information about testing practices and appropriate pharmaceuticals for treating seriously ill patients.
For full press release.
Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) Announces Availability of New Proposed Guideline: Molecular Diagnostic Methods for Infectious Diseases (MM3-P2)
Factors as current as the heightened threat of bioterrorism, and as gradual as increased human mobility brought about by innovations in travel, have led to a rising need for rapid identification of infectious agents. Because nucleic acid-based methods enable the quickest possible detection and identification of microorganisms, they are in high demand by clinical laboratories. In order to both help laboratories to validate and perform the growing number of commercial assays, and to develop assays for new applications, CLSI announces the availability of Molecular Diagnostic Methods for Infectious Diseases: Proposed Guideline—Second Edition (MM3-P2).
For full press release.
