ASM Clinical Microbiology Issues
Update
October 2001
PSAB Activities
Revised Anthrax Protocol Now Available
New Anthrax
Protocol
The ASM is pleased
to announce that the ASM/CDC/APHL Level A Laboratory Protocol for
Anthrax, authored by Dr. Jim Snyder, Dr. Daniel Shapiro, and Dr. Mary
Gilchrist, in coordination with the Centers for Disease Control and
Prevention, and the Association of Public Health Laboratories (APHL), is
now available and posted on the ASM web site. The protocol is designed to
assist clinical microbiology laboratories with information and
techniques for the presumptive identification of Bacillus
anthracis. As an interim
measure, the ASM has posted the CDC protocols for Plague, Tularemia,
Brucella, and other agents.
These protocols will be replaced by the ASM/CDC/APHL versions in
the near future. The Level
A Protocols offer clinical microbiology laboratories standardized,
practical methods to aid microbiologists in ruling out critical agents
and referring specimens to level B and C public health laboratories for
confirmation.
ASM
Resources on Biological Weapons Control and Bioterrorism
Preparedness
Resources Page
The ASM Office of Public
Affairs and the Office of Communications have prepared a compendium of
online resources and information relevant to Biological Weapons Control
and Bioterrorism Preparedness issues. The web site continues to be
updated as additional information becomes available. At this time of heightened
awareness about deterrence and preparedness, ASM members are advised to
exercise prudent attention to biosafety and vigilance concerning unusual
occurrences in the context of microbiology. ASM members should follow the
guidelines in Appendix F below for Laboratory Security and Emergency
Response for Microbiological and Biomedical
Laboratories.
Osterholm Testifies at Senate Hearing on
Bioterrorism
Osterholm
Testimony
On October 9, 2001,
Michael Osterholm, Director, Center for Infectious Disease Research and
Policy, and Professor, School of Public Health, University of Minnesota
and Chair of PSAB's Committee on Public Health, testified before the
Senate Committee on Health, Education, Labor, and Pensions, for a
hearing on Effective Responses to the Threat of Bioterriorism.
ASM Participates in Workgroup on Bioterrorism
Preparedness
Recommendations
On October 3, 2001,
the ASM participated in a Bioterrorism Preparedness workgroup meeting
organized by the University of Minnesota’s Center for Infectious Disease
Research and Policy, directed by Dr. Michael Osterholm. The Workgroup
prepared funding recommendations to aid the nation’s pubic health
infrastructure to deal with a biological attack.
ASM President-Elect Ron Atlas Participates in Washington Post
On-Line Program
Transcript
of On-line Chat
On October 11,
Dr. Ronald Atlas, ASM President-elect and Chair of the ASM Task Force on
Biological Weapons participated in the Washington Post on-line chat,
“America at War: Bioterrorism: Anthrax and Smallpox (2001).”
Changes
in Biological Weapons Statute in New Antiterrorism
Legislation
Legislation
Details
H.R. 3162,
antiterrorism legislation otherwise known as the PATRIOT Act, was
approved by the United States House of Representatives on October 24, by
the Senate on October 25, and signed into law by President Bush on
October 26. This new law
(Section 817) expands the biological weapons statute (Chapter 10 of
Title 18, United States Code) to make it an offense for a person to
knowingly possess any biological agent, toxin or delivery system of a
type or in a quantity that, under the circumstances, is not reasonably
justified by prophylactic, protective, bona fide research or other
peaceful purpose. H.R. 3162
also restricts certain persons from possessing a select agent listed in
Appendix A, Part 72 of Title 42, Code of Federal Regulations, which were
promulgated pursuant to Section 511 (d) of the Antiterrorism and
Effective Death Penalty Act of 1996 (Public Law 104-132). H.R. 3162
defines a restricted person.
The ASM was involved in the development of Section 817 and
supported its passage.
CMS Proposes Fees for New Lab Tests to be Included in 2002 Lab
Fee Schedule
Summary of
Meeting
ASM
Statement
CLIA Waiver
Update
ASM
Comments
FDA Web
Page
The Food and
Drug Administration is dropping its draft guidance on criteria for
waiver under the Clinical Laboratory Improvement Amendments of 1988
(CLIA). Over 70 comments
were received from a variety of groups, including the ASM, concerning
the CLIA draft guidance document.
The Centers of Medicare and Medicaid Services (CMS) now retains
authority to interpret CLIA and establish a final rule on the criteria
for waiver, in consultation with CDC and FDA. In the interim, waiver criteria
will be based on the 1995 CDC proposed rule and the FDA will apply
alternatives to the criteria in the 1995 proposed rule, only if CMS
believes the alternatives meet the statutory criteria. There is no mechanism in place
to rescind currently waived tests.
For more information on CLIA waivers and to see the list of
currently waived tests, please go to the FDA Web Page.
ASM
Represented at FDA Roundtable Meeting
Meeting
Summary
On October 4,
Ronald Zabransky, member of the Laboratory Practices Committee
represented the ASM at the FDA Roundtable meeting. Issues discussed were the CLIA
Waiver process (see related article), guidelines for “home brew” tests,
and approval of over-the-counter tests.
ASM News,
Journal Articles and Updates
ASM
Audioconference on Bioterrorism
Meetings (scroll to
audioconferences)
“Agents of
Bioterrorism: Detection, Handling and Shipping,” an ASM audioconference
presented by Dr. Jim Snyder, University of Louisville School of
Medicine, Louisville, KY, will occur on November 14, 2001, at 3:00pm,
EST. Updated information
regarding Level A protocols, the laboratory response network, specific
tests that have been identified to “rule-out” specific biological
agents, current guidelines for the safe shipping and transportation, as
well as recent experiences of the University of Louisville microbiology
laboratory working with the Kentucky State Department Health Laboratory,
will be provided by Dr. Snyder.
The registration deadline is November 6 and ASM will e-mail the
Microsoft Power Point presentation to each facility on Friday, November
9.
ASM Cosponsors
Audioconference with CDC
ASM has been
invited by the Centers for Disease Control and Prevention (CDC) to
cosponsor a satellite videoconference and webcast, “Laboratory
Preparedness and Response to Bioterrorism.” The videoconference and
webcast will be held Friday, November 9, 2001, from 1:00pm - 2:30pm
EST. The videoconference
will provide laboratorians in public health laboratories, hospital and
independent laboratories a special update designed to review how to
correctly receive, test, identify and appropriately refer specimens and
isolates that could be attributed to a bioterrorist event. Several ASM members will be
panelists in the program, including Fred Tenover, Tanja Popovic, Mike
Miller, Bob Martin, Norman Crouch and Susan Sharp. ASM will send out a separate
alert with information on how to participate, shortly.
ASM
Cosponsors AACC Audioconference on Bioterrorism
Meeting
Information/Registration
Academy Report on
Bioterrorism
Report
The American Academy
of Microbiology joined with the American College of Microbiology to
examine the central roles of professional microbiologists and clinicians
in recognizing the occurrence of possible bioterrorism events. Issues of
medical laboratory and practitioner training, emergency preparedness
plans, public education, collaboration, and communication across health
care and law enforcement agencies from the local to the federal level
are discussed in “Bioterrorism Threats to our Future, the Role of the
Clinical Microbiology Laboratory in Detection, Identification, and
Confirmation of Biological Agents.”
ICAAC
Update: New session on
Bioterrorism Added to Program
http://www.icaac.org/
ASM President-elect,
Ronald Atlas, in conjunction with the ICAAC Program Committee, has
organized a special symposium on Bioterrorism Preparedness.
The ICAAC Program
Committee recognizes that major scientific discoveries and important
disease outbreaks may have occurred since the original latebreaker
abstract submission deadline of August 21, 2001. Therefore, to ensure
the most current content at this year's meeting, the 41st ICAAC abstract
submission site has re-opened through November 19, 2001. Please be
advised that this will be highly competitive, with the Program Committee
only considering the most newsworthy science. For more information, please go
to http://www.asmusa.org/mtgsrc/41icaacDecCall.htm
Internet
Resources for Microbiology
New
Search Engine
The search engine
previously offered by ASM has been replaced. ASM now offers a resource
for members to facilitate the retrieval of reliable, relevant
information on the Internet and to contribute to the content and
organization of microbiology sites.
Legionella
Publication Now Available at ASM Press
ASM Press
Legionella, a new
publication available from ASM Press, offers a comprehensive overview on
recent findings and current opinions on Legionella research, covering
all aspects of pathogenesis, diagnosis, treatment, prevention, and
surveillance of Legionnaires’ disease.
Additional Information and
Updates
NCCLS
Approves New Guideline for Immunological Testing for Infectious
Disease
NCCLS
Web Page
NCCLS
has recently published I/LA 18-A2, “Specifications for Immunological
Testing for Infectious Disease: Approved Guideline –Second Edition.” The
guideline outlines specimen requirements; performance criteria;
algorithms for the
potential use of sequential or duplicate testing; recommendations for
intermethod comparisons of immunological test kits for detecting
infectious diseases; and specifications for development of reference
materials. The new guideline replaces I/LA 18-A.
New IOM Report on Tools for Evaluating the
MMRS
Full
Report
Report Summary
For
the last 5 years the United States Department of Health and Human
Services (DHHS) has been contracting with the most heavily populated
U.S. cities in an effort to improve those cities' capabilities to
respond to terrorism incidents of the scale on the September 11, 2001
attacks on the World trade Center and the Pentagon. This effort, the Metropolitan
Medical Response System (MMRS) program, provides cities with funds for
special equipment and a cache of pharmaceuticals and medical supplies,
and in turn demands detailed plans on how the city will organize and
respond to chemical and biological terrorism incidents.
The
Institute of Medicine (IOM) was asked to assist DHHS in assessing the
effectiveness of the MMRS program by developing appropriate evaluation
methods and processes. In this Phase I report the committee responds to
a list of 11 specific questions posed by Office of Emergency
Preparedness and provides a collection of almost 500 potential measures
of local preparedness. Addressing such activities as initial
identification of the toxic chemical or pathogen, decontamination, and
the transportation and treatment of victims, these measures will form
the basis of the comprehensive assessment system that will be the
product of Phase II of the
project.