Continuation Guidance -- Budget Year Five

Attachment D

Focus Area D: Laboratory Capacity -- Chemical Agents

Background

The purpose of this focus area is to develop nationwide laboratory
capacity that provides rapid and effective analysis of clinical
specimens (e.g., blood and urine) for chemical agents likely to be used
in terrorism. These laboratory measurements will help guide emergency
medical care, public health management of a chemical terrorism incident,
and follow up of a chemical terrorism incident event by identifying the
chemical agent(s) used, determining who has been exposed and how much
exposure each person has had.

This focus area also addresses laboratory analyses of food specimens for
chemical agents likely to be used in terrorism. The intent is to enable
awardees to gain access to capabilities needed in their jurisdictions.
This may be done by contracting for services with laboratories that
possess the requisite capabilities, by sponsoring such capability
development within collaborating organizations (e.g., food regulatory
laboratories), and/or by developing the requisite capabilities directly
within public health department laboratories. Technical assistance with
respect to selection of analytic methods will be provided by the Food
and Drug Administration (FDA) in consultation with CDC (see Appendix 1
for FDA contact information).

With respect to analysis of clinical specimens, the envisioned
nationwide capability has three levels of laboratory capacity.

[Level-One Laboratories:]{.underline} Awardees are eligible to receive
funding to support a chemical terrorism laboratory coordinator and
technical assistance/training to assist in management of laboratory
assets and to properly collect and ship human blood and urine specimens
in response to a chemical terrorism incident. Chemists and/or medical
technologists will staff this function. Awards for Level-One
laboratories will be limited to \$400,000 per awardee.

[Level-Two Laboratories:]{.underline} Awardees that already have
established or are in the process of establishing the capabilities of
Level-One laboratories are eligible to receive financial support,
technical assistance, equipment and training for analysis of human
samples for Level-Two industrial chemicals, selected chemical threat
agents (such as heavy metals, lewisite, and cyanide), or their
metabolites. Development of Level-One and Level-Two capabilities may be
concurrent activities. Level-Two laboratories will be equipped with
state-of-the--art instrumentation including automated sample preparation
equipment. These laboratories should be staffed with one Ph.D. chemist,
or an individual with equivalent experience, and multiple laboratory
support personnel.

To be eligible for Level-Two funding, the recipient must document a
basic level of staff competency in analytical/clinical chemistry and
laboratory quality control in measurements of low concentrations of
chemicals or metabolites in clinical samples. Evidence of such
competency would include a laboratory program in existence for at least
one year involving the quantitative measurement of low levels of a toxic
chemical, chemical metabolite, or biochemical indicator of health status
or disease risk in blood, urine, or other human specimens, or in
environmental specimens (e.g. blood lead analysis program, Environmental
Protection Agency (EPA) certification for chemical contaminant analyses
of drinking water, or Clinical Laboratory Improvement Amendments (CLIA)
certification for clinical chemistry measurements). Awards for level two
laboratories will be limited to \$1,200,000 per grantee.

[Level Three Laboratories:]{.underline} Five laboratories (California,
Michigan, New Mexico, New York, and Virginia) will be funded to maintain
capabilities of Level-Two laboratories, plus they will receive financial
support, technical assistance, equipment and training for analysis of
human samples for chemical threat agents that require a higher level of
analytical expertise (e.g. tandem mass spectrometry). Such laboratories
will be equipped with state-of-the-art instrumentation similar to the
Level-Two laboratories but also will have more extensive automated
sample preparation equipment and tandem mass spectrometers as necessary.
These laboratories will be staffed with multiple Ph.D. chemists, or
individuals with equivalent experience (M.S. with 5 years experience),
and multiple support personnel. Awards for level three laboratories (CA,
MI, NM, NY and VA) will not exceed \$1,600,000 per grantee.

CRITICAL CAPACITY #10 (Level-One Laboratories): To develop and implement
a jurisdiction-wide program that provides rapid and effective laboratory
response for chemical terrorism by establishing competency in collection
and transport of clinical specimens to laboratories capable of measuring
chemical threat agents.\
\
[Recipient Activities:]{.underline}

1.  **CRITICAL BENCHMARK #15 -- APPLICABLE TO LEVEL-ONE LABORATORIES:**
    Hire and train a chemical terrorism laboratory coordinator (chemist
    or medical technologist) and assistant coordinator to advise the
    laboratory director, the State Terrorism Coordinator and other
    public health and environmental health officials about chemical
    terrorism incidents and preparedness. These individuals are
    responsible for ensuring the proper collection, labeling, and
    shipment of blood, urine, and other clinical specimens required in
    response to known or suspected chemical terrorism incidents and for
    ensuring associated data and communication requirements are met.

2.  Develop a component, incorporated within the comprehensive response
    plan, directing how public health, food testing, environmental
    testing, and other laboratories within your jurisdiction will
    respond to a chemical terrorism incident. The plan must include (a)
    roles and responsibilities, (b) inter- and intra-jurisdictional
    surge capacity, (c) a description of how the plan integrates with
    other department-wide emergency response efforts, (d) protocols for
    the safe transport of specimens by air and ground, and (e) a
    mechanism for reporting laboratory data to public health officials,
    law enforcement agencies, and other chemical terrorism LRN
    laboratories. **(LINK WITH ALL OTHER FOCUS AREAS)**

3.  Establish and document in the comprehensive response plan,
    relationships with local members of HazMat teams, first responders,
    local, state, and federal law enforcement, and the Army National
    Guard (WMD-CST) to coordinate laboratory support for response to
    chemical terrorism with their response activities.

4.  Join the chemical terrorism component of the Laboratory Response
    Network (LRN) and ensure that capacity exists (within the state,
    through partnerships with Level-Two and/or Level-Three laboratories
    in other states, or CDC) for validated testing of chemical agents in
    clinical specimens.

5.  Enhance relationships with other chemical terrorism-related
    resources such as poison control centers, emergency medical
    personnel, medical toxicologists, food regulatory laboratories,
    schools of public health, and other partners with a view to ensuring
    that medical and public health officials have the benefit of at
    least preliminary chemical laboratory analyses in time to facilitate
    both the care of victims and the management of the incident. To this
    end, sponsor outreach efforts, professional conferences, and
    meetings.

ENHANCED CAPACITY #7 (Level-Two laboratories): In addition to
establishing Level-One capacity, Level-Two Laboratories are to establish
adequate and secure laboratory facilities, reagents, and equipment
(e.g., ICP-MS, GC-MSD) to rapidly detect and measure in clinical
specimens Level-Two chemical agents (such as cyanide-based compounds,
heavy metals, and lewisites). Currently, CDC methods for Level-Two
chemical agents use analytical techniques of inductively coupled plasma
mass spectrometry and gas chromatography mass spectrometry. The list of
Level-Two chemical agents may expand as better methods are developed.
Tandem mass spectrometry methods are not required for Level-Two chemical
agents. *Prerequisite: To be eligible for Level-Two funding, the
recipient must document a basic level competency in analytical chemistry
and laboratory quality control in measurements of low concentrations of
chemicals in clinical samples. Evidence of such competency would include
a laboratory program in existence for at least one year that includes
the quantitative measurement of low levels of a chemical in blood,
urine, or environmental specimens (e.g., blood lead analysis program,
EPA certification for chemical contaminant analyses of drinking water,
or CLIA certification for clinical chemistry measurements).\
*

[Recipient Activities:]{.underline}

1.  Develop or enhance plans and protocols that address: (a) clinical
    specimen transport and handling, (b) worker safety, (c) appropriate
    Bio-Safety Level (BSL) conditions for working with clinical
    specimens, (d) staffing and training of personnel, (e) quality
    control and assurance, (f) internal and external proficiency
    testing, (g) triage procedures for prioritizing intake and testing
    of specimens or samples before analysis, (h) secure storage of
    critical agents and samples of forensic value, and (i) appropriate
    levels of supplies and equipment needed to respond to chemical
    terrorism events. This should be documented in your comprehensive
    response plans.

2.  Level-Two laboratories must, in collaboration with CDC, purchase
    equipment, hire and train staff, implement analytical methods,
    participate in proficiency testing programs, and demonstrate
    competency in the analysis of Level-Two chemical agents or their
    metabolites in human specimens. Level-Two laboratories must achieve
    CLIA certification within 18 months of funding.

3.  **CRITICAL BENCHMARK #16 -- APPLICABLE TO LEVEL-TWO LABORATORIES
    ONLY:** Participate in at least one exercise per year that
    specifically tests chemical terrorism laboratory readiness and
    capability to detect and identify at least one chemical-threat
    agent.

4.  Use BSL-2 practices, as outlined in the CDC-NIH publication
    "Bio-safety in Microbiological and Biomedical Laboratories, 4^th^
    Edition" (BMBL), to process clinical specimens (e.g., blood and
    urine) \-- see [www.cdc.gov/od/ohs](http://www.cdc.gov/od/ohs). CDC
    also recognizes the need that state laboratories have to safely
    handle unknown environmental samples. Laboratories are encouraged to
    participate with federal partners, the LRN, HAZMAT, first
    responders, and other state public health laboratories to develop
    and disseminate standardized methods, procedures, and protocols to
    safely triage, aliquot, transfer, ship, and store unknown clinical
    or environmental specimens potentially containing chemical,
    biological, radiological, or explosive agents. **(LINK WITH FOCUS
    AREA C)**

5.  At a minimum, ensure that laboratory security is consistent with
    standards set forth in the Select Agent Rule or subsequent updates.
    Note that pursuant to 18 USC section 175b, as amended by section 817
    of the USA PATRIOT Act of 2001, P.L. 107-56, aliens (other than
    aliens lawfully admitted to the United States for permanent
    residence) are prohibited from possessing select agents if they are
    nationals of countries about which the Secretary of State (pursuant
    to provisions of the Export Administration Act of 1979, the Foreign
    Assistance Act of 1981, or the Arms Export Control Act) has made an
    unrevoked determination that such countries have repeatedly provided
    support for acts of international terrorism.

6.  Enhance and document Internet connectivity to enable rapid
    communication via the Internet for information and data transfer
    with chemical laboratories in the LRN. **(LINK WITH FOCUS AREAS C
    and E)**

    **Enhanced capacity #8 (Level-Three laboratories):** In addition to
    maintaining Level-One and Level-Two capacity, Level-Three
    laboratories are to establish adequate and secure laboratory
    facilities, reagents, and equipment (e.g., tandem mass spectrometer)
    to rapidly detect and measure in clinical specimens Level-Three
    chemical agents (such as nerve agents, mustards, mycotoxins, and
    selected toxic industrial chemicals). Level-Three laboratories will
    also provide surge capacity to CDC and serve as referral
    laboratories for Level-One and Level-Two laboratories. The five
    laboratories currently funded under Focus Area D (California,
    Michigan, New Mexico, New York and Virginia) are considered
    Level-Three laboratories. It is CDC's intent in the future to add up
    to five additional laboratories at Level-Three. *Prerequisite: To be
    considered for acceptance into Level-Three, a laboratory must
    demonstrate analytical competency at Level-Two, including success in
    an accepted proficiency testing program for all Level-Two chemical
    agents (e.g., heavy metals, lewisites, cyanide).*

[Recipient Activities:]{.underline}

1.  Level-Three laboratories must, in collaboration with CDC, purchase
    equipment, hire and train staff, implement analytical methods,
    participate in proficiency testing programs, and demonstrate
    competency in the analysis of Level-Three chemical agents or their
    metabolites in blood and urine.

2.  **CRITICAL BENCHMARK #17 -- APPLICABLE TO LEVEL-THREE LABORATORIES
    ONLY:** Participate in at least one exercise per year that
    specifically tests chemical terrorism laboratory readiness and
    capability to detect and identify at least two chemical-threat
    agents.

3.  In collaboration with CDC and other Level-Three laboratories,
    participate in method development and validation studies.

4.  Provide surge capacity to CDC and serve as a referral laboratory for
    Level-One and Level-Two laboratories.

5.  Develop and implement a plan for 24/7 staff coverage in the event of
    a chemical terrorism emergency. Documentation of this plan should be
    provided to CDC to coordinate efforts.