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Interim Progress Report - Budget Period Three
Workplan - Budget Period Four
Critical Capacity 10: Level One Laboratories
1. Hire chemical terrorism lab coordinator and
assistant coordinator
2. Include laboratory response to chemical
incident in comprehensive emergency response plans
3. Establish relationships with HazMat teams,
first responders, local, state, and federal law enforcement, and the
Army National Guard.
4. Ensure state capacity (through partnerships)
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
Enhanced Capacity 7: Level Two Laboratories
1. Develop or enhance laboratory response plans and
protocols
2. 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 necessary to achieve CLIA certification.
3. (Critical Benchmark 16) Include Level Two
laboratories in statewide preparedness exercises.
4. Use federally recommended procedures for handling
specimens.
5. Meet federal standards for laboratory security
Enhanced Capacity 8: Level Three
Laboratories
Budget Period Three Progress Report
NOTE: Progress report applies only to California, Michigan, New Mexico,
New York, and Virginia
Using the space below, provide a brief status report on your Focus Area
D Laboratory Capacity. The progress report narrative should not exceed 1
page, single-spaced. Applicants are welcome to use bullet-point format in
their answers, so long as the information is clearly conveyed in the
response.
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Budget Year Four Workplan
For each Recipient Activity applicants should complete the work plan
templates attached below. Applicants are welcome to use bullet-point
format in their answers, so long as the information is clearly conveyed in
the response. All responses should be brief and concise. Please note
that full use of the CDC templates will meet all of the requirements for
submission of a progress report and work plan. Although no additional
information is required, grantees may elect to submit other essential
supporting documents via the web portal by uploading them as additional
electronic files.
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:
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.
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. In cooperation with Epidemiologist from the DOH Office of
Non-Infectious Disease Epidemiology (NICE) generate a plan of
activities for a chemical terrorism laboratory coordinator (CTLC)
and assistant chemical terrorism laboratory coordinator (ACTLC) with
clear definitions of their roles and responsibilities and expected
output of their work.
2. Recruit and hire a chemical terrorism laboratory coordinator (CTLC)
and an assistant chemical terrorism laboratory coordinator (ACTLC)
3. Train hired CTLC and ACTLC through attendance of training
classes, seminars, and conferences (LINK to Focus Area G).
4. Develop protocols for proper collection, labeling, and
shipment of blood, urine, and other clinical specimens in response
to chemical terrorism.
5. Train statewide clinical laboratory personnel to ensure that
chemical terrorism response related clinical specimens are
collected, labeled, and shipped properly (LINK to Focus Area C and
G).
6. Develop protocols for proper communication of actions and data
associated with collection and testing of clinical specimens during
chemical terrorism response event and providing training to local
health officials statewide about communication of chemical terrorism
related specimen data (Link to Focus Areas A, C, and G).
|
Tasks: What key tasks will be conducted in carrying out each identified
strategy?
|
1a Define duties and skills requirements for CTLC and ACTLC.
1b Identify clear expectations of CTLC and ACTLC work for the
2003-04 grant period.
2a Conduct searches for candidates for CTLC and ACTLC positions.
2b Interview and select candidates with skills and experience
that fit the defined CTLC and ACTLC positions.
2c Purchase equipment/supplies to support FTE.
3a Develop a formal plan for training of CTLC and ACTLC.
3b Register CTLC and ACTLC for training sessions, seminars,
conferences, and hands on training (include travel as necessary).
4a Consult with Centers for Disease Control and Prevention (CDC),
Association of Public Health Laboratories (APHL), Focus Area C for
instructions/recommendations on collecting, labeling, and shipping
specimens.
4b Develop protocols for collection, labeling and shipment of
chemical terrorism specimens for state of Washington Laboratory
Response Network (LRN)..
4c Review draft protocols with CDC, APHL, NICE Epidemiologist,
and Focus Area C.
4d Incorporate changes in finalized protocols.
5a Publish and distribute protocols to state-wide clinical
laboratories.
5b Provide training to state-wide clinical laboratories on
collection, labeling, and shipment of chemical terrorism specimens.
6a. Consult state and local public health officials regarding
proper channels of communication of information associated with
collection and testing specimens during a chemical terrorism event.
6b Write protocols describing approved communication of
information and data associated with chemical terrorism specimens.
6c Add this protocol to the State LRN reporting system and
distribute to local/state officials and statewide laboratories.
6d Train local health officials and statewide labs on proper
communication of information and data associated with chemical
terrorism response specimens developing training material and
providing training (LINK to Focus Area G).
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a CTLC and ACTLC positions specs, 08/ 2003
1b List and description of expected accomplishments for grant
period 2003-04, 09/2003
2a Position announcement, review of applications, interviews,
10/2003
2b Job offers, ELS OD, NICE Epi, 11/03
2c Purchase order, 11/03
3a Plan of training, 11/2003
3b Schedule of training, travel, conference attendance - Ongoing
2003-2004
4a Consultation with CDC and APHL, 01/2004
4b Draft protocol ready for review, 02/ 2004
4c Convene a panel for protocol review, 02/2004
4d Comments from review panel are received and protocol
finalized, 03/2004
5a Protocol is distributed, 04/2004
5b Training is provided, 05/2004
6a Consultation input received, 02/2004
6b Protocol is available, 03/ 2004
6c Protocol published in LRN and sent to state-wide laboratories
and local health officials, 04/ 2004
6d Training of state-wide laboratories and local health officials
- Ongoing 2004
|
Responsible Parties: Identify the person(s) and/or entity assigned to
complete each task.
|
1a DOH Environmental Laboratory Sciences (ELS) Office Director
and NICE Epidemiologist
1b ELS Office Director and NICE Epidemiologist
2a ELS Office Director responsible for ACTLC position and NICE
Epidemiologist responsible for CTLC position
2b NICE Epidemiologist, ELS Office Director
2c ELS Office Director
3a NICE Epidemiologist, ELS Office Director
3b ELS Office Director
4a CTLC
4b CTLC, ELS Office Director
4c CTLC
4d CTLC and ACTLC
5a ACTLC
5b ACTLC
6a CTLC
6b CTLC and ACTLC
6c ACTLC
6d ACTLC
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Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
- By the end of the grant year DOH will have hired and
trained chemical terrorism coordinator and assistant chemical
terrorism coordinator.
- Protocols for chemical terrorism specimen collection,
labeling and shipping and protocol for communication of chemical
terrorism specimen information and data will be developed and
distributed to local health officials and state-wide laboratories.
- Training of local health officials and statewide
laboratories on proper specimen collection and shipping, as well as
proper communication of specimen information will be in progress.
|
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2. Develop a component, incorporated within the comprehensive
response plan, that directs 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)
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Conduct a survey of all governmental (Federal, State, and LHJ),
hospital, private, and Academic laboratory facilities within the
state potentially available to participate in chemical terrorism
response for coordinating and performing clinical, food, and
environmental testing.
2. Conduct an assessment of the existing capabilities of surveyed
laboratories for testing specimens and/or transporting/shipping
specimens (LINK to Focus Areas A, C, and G).
3. Formulate a plan to develop and enhance the capabilities of
laboratories designated for testing or shipping of clinical
specimens or food and environmental samples in response to chemical
terrorism incident. Define the roles and responsibilities of these
laboratories in the state laboratories network for chemical
terrorism response. Integrate EPA, FDA, and other federal partner’s
programs and initiatives into a plan to develop/enhance laboratory
capacity (LINK to Focus Areas A, C, and G).
4. Build a network of inter- and intra-jurisdictional surge
capacity for each local testing laboratory and develop memoranda of
understanding (MOUs) with surge capacity laboratories.
5. Build a laboratory chemical terrorism state response network
that integrates with other department-wide emergency response
efforts such as the Emergency Operations Center, Bioterrorism
Coordinator, City and County Emergency Response Organizations,
National Guard, Civil Support Team, etc.
6. Develop protocols for the safe transport of specimens by air
and ground and distribute them to local laboratories.
7. Develop a mechanism for reporting laboratory data to public
health officials, law enforcement agencies and other chemical LRN
laboratories (LINK to Focus Area C).
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Tasks: What key tasks will be conducted in carrying out each identified
strategy?
|
1a Working with Focus Areas B & C, the regional Food and Drug
Administration (FDA) and Environmental Protection Agency (EPA);
Washington State Department of Energy (DOE), DOH Division of
Environmental Health, the University of Washington (UW), Washington
State University (WSU), and local health jurisdictions (LHJs) make a
list of all laboratories within the state that test human specimens,
food, and environmental samples.
1b Prepare a survey questionnaire to identify laboratories that
perform testing on clinical and/or food/environmental samples for
chemical agents and laboratories that ship specimens or samples.
1c Send the survey out to the laboratories identified in 1a,
above.
1d Follow up by directly contacting laboratories that did not
respond to the survey.
2a Analyze survey data
2b Compile the survey data by geographical areas and assess the
existing capabilities of laboratories in each area.
2c Review the survey data with state coordinators for developing
Washington State preparedness for biological and chemical emergency
responses.
3a Establish a network of local laboratories responsible for
testing or shipment of specimens/samples that ensures that each
region within the state has the laboratory capability to respond to
chemical terrorism event.
3b Define roles and responsibilities within the network of local
laboratories in the state plan for preparedness to chemical
terrorism event response. (LINK to Focus Area G)
3c Identify development/enhancement of capability and capacity
needed for each network laboratory.
3d Present laboratory network response plan to stakeholders.
4a Coordinating with local health officials, CDC, EPA, FDA, and
other federal partners identify facilities in each area of the state
(or neighboring states) to be used as surge capacity laboratories
for chemical terrorism response.
4b Establish a relationship with these laboratories and create
agreements for using them as a surge capacity laboratory.
5a Share the chemical terrorism laboratories network response
plan with DOH Biological and Radiation terrorism response
coordinators.
6a Consult agencies responsible for setting safety rules for air
and ground transportation of biological and chemical toxic
materials.
6b Consult CDC and APHL on their protocols for transporting
biological and chemical toxic materials by air and ground.
6c Write WAPHL protocols for transporting specimens/samples
collected in response to chemical terrorism by air and ground.
7a Discuss with NICE epidemiologist, Washington DOE, DOH Division
of Environmental Health, FDA, and EPA, what mechanism needs to be
developed for proper channels of reporting of test results.
7b Develop a reporting protocol specifying how lab results will
be reported and shared with public health officials and law
enforcement agencies.
7c Include reporting protocol in training plans. (LINK to Focus
Area G)
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a List of laboratories, 01/2004
1b Survey questionnaire, 02/2004
1c Surveys mailed to laboratories, 01/2004
1d Contacts made with no-response laboratories, 03/2004
2a Surveys are reviewed, 03/2004
2b Survey data compiled, 03/ 2004
2c Compiled data, 04/2004
3a Network, 04/2004
3b Local laboratories roles/responsibilities defined, 05/2004
3c Plan of developing laboratories capabilities, 06/2004
3d Plan of developing laboratories network is presented, 07/2004
4a Identified surge capacity labs, 07/2004
4b Established agreements with surge capacity labs, 08/2004
5a Information shared, 08/2004
6a Information acquired, 08/2004
6b Information acquired, 07/2004
6c Protocol, 07/2004
7a Documentation of discussions, 06/2004
7b Developed protocol, 07/2004
7c Training materials, 07/2004
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Responsible Parties: Identify the person(s) and/or entity assigned to
complete each task.
|
1a ELS Office Director
1b ELS Office Director
1c ELS Office Director
1d ELS Office Director
2a ELS Office Director
2b ELS Office Director
2c CTLC
3a PHL Director
3b PHL Director
3c ELS Office Director
3d CTLC
4a PHL Director
4b PHL Director
5a CTLC
6a ELS Office Director
6b ELS Office Director
6c ELS Office Director
7a CTCL,
7b CTCL
7c ELS Office Director
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Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
- By the end of the 2003-04 grant period, the WAPHL will
assess state-wide laboratory capabilities and establish a laboratory
network for chemical terrorism response.
- The WAPHL will have a plan in place to develop and
enhance laboratory response capacities throughout the state.
|
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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.
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Establish relationships with laboratories and local, state and
federal members first responders, HazMat teams, law enforcement, and
Army National Guard (LINK to Focus Areas A and C).
2. Establish protocols for sample collection and
transportation/shipping
3. Train first responders in proper sample collection for
laboratory testing in response to chemical terrorism event (LINK to
Focus Area G).
4. Create a database of organizations and contact of first
responders throughout the state.
|
Tasks: What key tasks will be conducted in carrying out each identified
strategy?
|
1a Working with Focus Ares A and C, state and local law
enforcement, Department of Transportation, local fire departments,
and federal partners, develop a list of first responders in
Washington State
1b Meet with key partners of the local first responders.
1c Develop a plan of coordinated actions between laboratories and
first responders in the event of chemical terrorism.
2a Working with first responders, write protocols for
specimen/sample collection and transportation.
3a Develop training workshop to educate first responders in
proper specimens/samples collection, initial screening, chain of
custody, and transportation.
3b Sponsor periodic training sessions for first responders.
4a Collect contact information for local first responders and
enter information in the first responders database.
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a List of first responders, 04/2004
1b Meetings schedule, 05/2004
1c Developed plan, 05/2004
2a Written Protocols, 06/2004
3a Training conducted, 07/2004
3b Training schedule, 07/2004
4a Database available, 07/2004
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Responsible Parties: Identify the person(s) and/or entity assigned to
complete each task.
|
1a ELS Office Director
1b ELS Office Director
1c CTLC
2a ELS Office Director
3a ELS Office Director
3b ELS Office Director
4a PHL Training Manager
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Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
- By the of the grant period the WAPHL will identify
first responders across the state and establish response and
communication protocols.
- First responders will be incorporated into the overall
state emergency response plan and will have a clear understanding of
their roles and responsibilities.
|
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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.
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Through PHL Director join the Laboratory LRN as the chemical
terrorism component for the state of Washington.
2. Establish relationships with the Level-Three laboratories for
validated testing of chemical agents in clinical specimens from
Washington State.
|
Tasks: What key tasks will be conducted in carrying out each identified
strategy?
|
1a Join LRN for the chemical terrorism component.
2a Identify out-of-state Level-Three Laboratories available for
validated testing of chemical agents in specimens from Washington
State.
2b Contact Level-Three Laboratories and obtain their operational
and testing procedures.
2c Establish MOU with the Level-Three Laboratories for specimen
testing.
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a LRN membership code, 12/2003
2a Identified Laboratories, 09/2003
2b Documentation of Contacts, 10/2003
2c MOU established, 12/2003
|
Responsible Parties: Identify the person(s) and/or entity assigned to
complete each task.
|
1a PHL Director
2a PHL Director
2b ELS Office Director
2c PHL Director
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
| By the end of 2003-04 grant period the WAPHL will
establish formal working relationships with existing Level-Three
laboratories. |
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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.
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Establish relationships with State of Washington and local
Poison Control Centers, local Emergency Medical Personnel,
Toxicology laboratories, Regional FDA Laboratory, and University of
Washington School of Public Health
2. Establish relationship with local medical and public health
officials and organizations.
3. Include chemical terrorism response partners in the protocol
for reporting lab results specifying how (through what channels) lab
results will be shared with them.
4. Sponsor outreach efforts for partners to attend state meetings
and conferences related to the state chemical terrorism preparedness
and events
5. Develop a database of contact information for chemical
terrorism-related organizations.
|
Tasks: What key tasks will be conducted in carrying out each identified
strategy?
|
1a Contact key personnel at poison control centers, emergency
medical centers, the State of Washington Toxicology Laboratory, the
Regional FDA Laboratory, the University of Washington School of
Public Health, Washington State University and similar
organizations/agencies within the state.
1b Meet with key personnel to discuss WAPHL activities for
developing state public health preparedness for response to chemical
terrorism.
2a Identify local health officials and professional organizations
and attend conferences and meeting as appropriate.
2b Provide training materials and speakers for meeting with
professional groups (LINK to Focus Area G).
2c Provide training about the LRN system and its operations (Link
to Focus Area G).
3a Develop data-sharing protocol including a communication plan
with chemical terrorism-related resources.
3b Share this protocol with partners.
4a Invite partners to upcoming meetings/conferences.
4b Sponsor attendance of meeting/conferences.
4c Publish articles and chemical terrorism training classes
schedules in Elaborations newsletter
4d Attend local and national chemical terrorism related
conferences.
5a Identify resources and create a database of contacts for
distribution of chemical terrorism related information.
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a Contacts documented, 12/2003
1b Meeting agenda, 02/2004
2a Local health officials identified, 12/2003
2b Meeting agenda - Ongoing 2003-04
2c Training Materials, 07/2004
3a Protocol, 07/2004
3b Protocol distributed, 07/2004
4a Schedule of meeting - Ongoing 2003-04
4b Schedule of meetings - Ongoing 2003-04
4c Articles, training schedule - Ongoing 2003-04
4d Conferences schedule - Ongoing 2003-04
5a Database, 08/2004
|
Responsible Parties: Identify the person(s) and/or entity assigned to
complete each task.
|
1a CTCL
1b CTCL
2a-5a ELS Office Director
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
| By the end of the grant period the WAPHL
will have its network of chemical terrorism resources expanded to
include emergency medical groups, poison control centers,
universities, food regulatory and other organizations. The WAPHL will
sponsor outreach activities including meetings, conferences, and
training. |
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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:
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.
Strategies: What overarching approach(es) will be used to undertake
this activity?
Note: The issue of basic laboratory competency
required to receive Level-Two funding is addressed in an attachment
"Washington State Public Health Laboratory Current and Past Expertise
in Performing Chemical Tests."
1. Develop, R.C.W. 42.17.310(1)(ww) protocol for specimen
transportation, receiving and handling at the PHL laboratory
2. Add, R.C.W. 42.17.310(1)(ww) appropriate BioSafety level
cabinet, 42.17.310(1)(ww) to the Chemistry Laboratory to provide
safe working conditions when handling clinical specimens.
3. Recruit and hire a PhD chemist and analytical chemist to work
on procedure implementation and test chemical agents in clinical
specimens.
4. In cooperation with CDC, APHL, and instrument vendors, provide
training in chemical analyses of clinical specimens. (LINK to Focus
Area G).
5. Develop and implement, R.C.W.42.17.310(1)(ww) quality control
(QC) and quality assurance (QA) components of the new,
R.C.W.42.17.310(1)(ww procedures for performance of chemical testing
on clinical specimens.
6. Develop and implement, R.C.W. 42.17.310(1)(ww) an internal
proficiency testing plan.
7. In cooperation with CDC and APHL, identify and implement,
R.C.W. 42.17.310(1)(ww available external proficiency testing
programs for testing chemical agents in clinical specimens.
8. Develop, R.C.W.42.17.310(1)(ww) a protocol for prioritizing,
R.C.W.42.17.310(1)(ww incoming specimens (triage).
9. Add storage facilities to the WAPHL to ensure secure storage,
R.C.W.42.17.310(1)(ww) of critical agents and samples of forensic
value.
10. Implement a plan to ensure the availability of supplies and
equipment needed to respond to chemical terrorism event.
11. Combine appropriate plans and protocols into a laboratory
chemical terrorism response manual.
|
Tasks: What key tasks will be conducted in carrying out each identified
strategy?
|
1a In cooperation with CDC, APHL, and the PHL Microbiology and
Radiation Laboratories identify, R.C.W.42.17.310(1)(ww) existing
protocols related to safe transportation, receiving and handling of
chemical terrorism specimens.
1b Establish R.C.W. 42.17.310(1)(ww) WAPHL protocols for safe
transportation, receiving and handling of chemical terrorism
specimens.
2a Perform a search R.C.W. 42.17.310(1)(ww) for the optimal model
of a BioSafety cabinet R.C.W. 42.17.310(1)(ww) for the Chemical
Laboratory application.
2b Purchase the approved model of BioSafety cabinet R.C.W.
42.17.310(1)(ww).
3a Recruit and hire a PhD (or equivalent) chemist as a lead
worker in analytical procedures implementation
3b Recruit and hire Chemist 1 or 2 as an analytical bench worker
to perform tests on clinical specimens.
3c Purchase equipment/supplies to support FTEs
4a Consult with CDC and APHL concerning availability of training
for testing. Contact instrument vendors concerning available
training for the operation of instruments.
4b Devise a training plan for new chemist positions.
4c Provide planned training.
5a In cooperation with CDC, identify R.C.W. 42.17.310 (1)(ww) QC
and QA components needed for testing chemical agents in clinical
specimens to assure the accuracy and precision of results.
5b Develop QC and QA plan to include in WAPHL test procedures.
6a Devise a plan to implement R.C.W. 42.17.310 (1)(ww) internal
proficiency testing of chemical agents.
6b Present the internal proficiency testing plan to the WAPHL QA
committee
6c Implement R.C.W. 42.17.310 (1)(ww) the new R.C.W. 42.17.310
(1)(ww) internal proficiency testing plan into the laboratory
testing algorithm.
7a Identify R.C.W. 42.17.310 (1)(ww) available external
proficiency testing programs for testing arsenic, cyanide R.C.W.
42.17.310 (1)(ww) and lewisites R.C.W. 42.17.310 (1)(ww) in clinical
samples.
7b Implement R.C.W. 42.17.310
(1)(ww) available proficiency testing programs.
8a Identify staff responsible for the prioritization of
specimens.
8b Identify critical control points in the triage process.
8c Write the pre-analytical prioritization (triage) protocol
9a Identify R.C.W. 42.17.310 (1)(ww) critical agents and the
requirements for secure storage.
9b Plan the construction of a secure storage R.C.W. 42.17.310
(1)(ww) facility at the WAPHL.
9c Implement the plan to construct a secure storage facility.
10a Identify R.C.W. 42.17.310 (1)(ww) the supplies and amounts
needed for an appropriate chemical terrorism response at the WAPHL
to ensure continual readiness.
10b Appoint an individual to be responsible for the availability
of chemical terrorism supplies within an expiration days at all
times.
10c Assign R.C.W. 42.17.310 (1)(ww) responsibilities to
laboratory personnel for keeping equipment and instruments in
operational condition at all times.
11a Assign R.C.W. 42.17.310 (1)(ww) responsibility for each
element of a laboratory chemical terrorism response manual.
11b Combine all the elements related to laboratory preparedness
for chemical terrorism response into a WAPHL chemical terrorism
response manual.
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a Needs documentation, 12/2003.
1b Protocol written, 01/2003
2a Model determined, 12/2003
2b Purchase order, 02/2004
3a PhD Chemist hired, 11/2003
3b Chemist hired, 11/2003
3c Order, 11/2003
4a List of available training, 10/2003
4b Training schedule, 11/2003
4c Training documentation, Ongoing 2003-04
5a Information for development, 01/2004
5b QC & QA plan, 02/2004
6a PHL QA committee meeting, 02/2004
6b Internal proficiency testing plan, 02/2004
6c Internal proficiency testing plan approved, 03/2004
7a External proficiency testing programs identified, 03/2004
7b Application for external proficiency testing plan, 08/2004
8a Contacts, 04/2004
8b Meeting agenda, 05/2004
8c Protocol, 05/ 2004
9a Identification, 04/2004
9b Plan, 04/2004
9c Implementation, 08/2004
10a List of supplies, 05/2004
10b Individual name and duties, 05/2004
10c Responsibilities assigned, 05/2004
11a Personnel names, 04/2004
11b Manual completed, 08/2004
|
Responsible Parties: Identify the person(s) and/or entity assigned to
complete each task.
|
1a-2b Lead Chemist
3a ELS Office Director
3b ELS Office Director
4a ELS Office Director
4b PHL Training Coordinator
4c ELS Office Director
5a Lead Chemist
5b Lead Chemist
6a ELS Office Director
6b ELS Office Director
6c Lead Chemist
7a Lead Chemist
7b ELS Office Director
8a ELS Office Director
8b ELS Office Director
8c ELS Office Director
9a ELS Office Director
9b PHL Operation Manager
10a ELS Office Director
10b ELS Office Director
10c ELS Office Director
11a ELS Office Director
11b Lead Chemist
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
| By the end of the grant period the WAPHL will have a
complete chemical terrorism response manual. |
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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.
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Purchase gas chromatography mass spectrum (GC MS) instrument
and MPS Prepstation for analyzing cyanide, lewisite, and VOC in
clinical specimens.
2. Purchase ICP MS instrument with auto sample injector for
analyzing arsenic and other metals
3. Purchase solvent concentrator
4. Purchase solid phase extractor
5. Purchase chemical fume hood
6. Purchase biological safety cabinet
7. Purchase -70°C freezer
8. Purchase solvent storage cabinets
9. Purchase acid and base cabinets
10. Purchase supplies of calibration materials, reagents, and
equipment parts
11. Recruit and hire PhD (or equivalent) chemist to be a Lead
Chemist for implementation of testing procedures and Analytical
Chemist, level 2, for performing tests.
12. Train hired chemists through attending training classes,
workshops, and seminars (LINK to Focus Area G).
13. Participate in proficiency testing programs.
14. Demonstrate competency in the analysis of Level-Two chemical
agents or their metabolites in human specimens by generating
accurate results for QC and proficiency testing specimens and
showing good laboratory practices in handling specimens and
performing analyses.
15. Achieve Clinical Laboratory Improvement Amendments (CLIA)
certification by January 2005
|
Tasks: What key tasks will be conducted in carrying out each identified
strategy?
|
1a Identify appropriate GC MS model
1b Purchase approved model
2a Identify appropriate ICP MS model
2b Purchase approved model
3a Identify appropriate solvent concentrator model
3b Purchase approved model
4a Identify appropriate solid phase extractor model
4b Purchase approved model
5a Identify appropriate chemical fume hood model
5b Purchase approved model
6a Identify appropriate biological safety cabinet
6b Purchase approved model
7a Identify -70°C freezer model
7b Purchase approved model
8a Identify appropriate solvent storage cabinet
8b Purchase approved model
9a Identify and purchase acid and base storage cabinet
10a Identify needed supplies of calibration material reagents and
equipment parts
10b Purchase needed supplies of calibration material reagents and
equipment parts
11a Define duties and skills of Lead Chemist and Analytical
Chemist
11b Conduct a search for candidates for Lead and Analytical
Chemists.
11c Interview and select candidates with skills and experience
that fit the most for the defined Lead and Analytical Chemists
positions
11d Purchase equipment/supplies to support FTE
12a Develop a formal training plan for training Lead and
analytical Chemists
12b Register Lead Chemist and Analytical Chemist for training
sessions, seminars, and hands on workshops including travel as
necessary.
13a Identify proficiency testing programs for testing chemical
agents in clinical specimens available nationally-wide
13b Implement appropriate proficiency testing programs.
14a Pass tests for the internal and external proficiency tests.
14b Pass tests on quality control samples
15a Apply for CLIA certification for chemical tests in clinical
specimens
15b Pass all CLIA requirements for granting a certification.
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a Plans, 12/2003
1b Purchasing, 01/2004
2a Plan, 12/2003
2b Purchasing, 01/2004
3a Plan, 12/2003
3b Purchasing, 01/2004
4a Plan, 12/2003
4b Purchasing, 01/2004
5a Plan, 12/2003
5b Purchasing, 01/2004
6a Plan, 12/ 2003
6b Purchasing, 01/2004
7a Plans, 01/2004
7b Purchasing, 02/2004
8a Plans, 01/2004
8b Purchasing, 02/2004
9a Purchasing, 11/2003
10a Plans for supplies, 12/2003
10b Purchasing, Ongoing
11a Defined duties and skill-sets, 09/2003
11b Announcement, 09/2003
11c Interview, hiring, 11/2003
11d Purchase order, 11/2003
12a Plan of training, 12/2003
12b Schedule of training, 11/ 2003
13a Proficiency testing programs, 10/2003
13b Application, 11/2004
14a Results, Ongoing
14b Evaluation of results, Ongoing
15a Application, 08/2004
15b Certification, 02/2005
|
Responsible Parties: Identify the person(s) and/or entity assigned to
complete each task.
|
All tasks ELS Office Director
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
| By the end of the 2003 - 2004 grant year, the WAPHL
will have analytical procedures and proficiency testing programs for
testing chemical agents in clinical specimens implemented in order to
be qualified to apply for CLIA certification at the beginning of the
following grant period. |
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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.
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Participate in at least one laboratory chemical terrorism
simulated exercise involving state, local, regional, hospital, and
federal (FDA, EPA, FBI, etc) partners (LINK to Focus Area A, C, and
G).
2. Evaluate exercise performance to identify strengths and
weaknesses and implement a plan for improvement (LINK to Focus Areas
A, C, and G).
|
Tasks: What key tasks will be conducted in carrying out each identified
strategy?
|
1a Plan an exercise in coordination with all divisions of DOH as
a whole and invite local an Federal partners, first responders, and
laboratories to participate.
1b Set up and sponsor planning meetings.
1c Conduct the exercise and document performance.
2a Sponsor a follow-up meeting between representatives of all
participants, analyze performance, and solicit ideas for
improvement.
2b With input from observers and co-participants, document
exercise performance
2c Document areas for improvement and develop an implementation
plan.
2d Implement improvement plan.
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a Plan, 04/200
1b Meeting, Ongoing 2004
1c Exercise plan and schedule, 06/2004
2a Meeting agenda, 07/2004
2b Report, 07/2004
2c Report, 07/2004
|
Responsible Parties: Identify the person(s) and/or entity assigned to
complete each task.
|
1a-2b Division ERP
2c ELS Office Director
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
| By participation in a simulation exercise, the WAPHL
will be able to evaluate its capability for handling chemical
terrorism agents as well as the state’s overall preparedness for
chemical terrorism response. |
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4. Use BSL-2 practices, as outlined in the CDC-NIH publication
"Bio-safety in Microbiological and Biomedical Laboratories, 4th
Edition" (BMBL), to process clinical specimens (e.g., blood and urine)
-- see 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)
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Consulting PHL Focus Area C group develop R.C.W.
42.17.310(1)(ww) internal bio-safety laboratory R.C.W.
42.17.310(1)(ww) capacity for working with human specimens (Link to
Activities of Enhanced Critical Capacity #7).
2. In cooperation with CDC, other federal partners (e.g., EPA,
FDA, etc.), first responders, and WAPHL Microbiology and Radiation
Laboratories, develop R.C.W. 42.17.310(1)(ww) protocols for
receiving and handling unknown specimen/samples.
3. Incorporate guidelines and protocols into the Central
Accessioning Plan at WAPHL.
|
Tasks: What key tasks will be conducted in carrying out each identified
strategy?
|
1a As outlined in Activity 2, above, purchase R.C.W.
42.17.310(1)(ww) equipment and supplies to ensure capacity to safely
R.C.W. 42.17.310(1)(ww) to receive and work with various unknown
specimens.
1b Develop R.C.W. 42.17.310(1)(ww) written procedures and
protocols for internal processing of samples.
1c Train internal staff on use of equipment and safe practices in
specimen handling (LINK to Focus Area G).
2a Consult with CDC, EPA FDA, FBI, industry associations, LRN,
etc., on safe-handling practices with unknown specimens.
2b Meet with WAPHL Microbiology and Radiation laboratories to
develop R.C.W. 42.17.310(1)(ww) a safe protocol for receiving
unknown specimens/samples.
2c In collaboration with the WAPHL staff write R.C.W.
42.17.310(1)(ww) a protocol for the receiving and handling of
unknown specimens/samples.
2d Provide training to partner laboratories and first responders
regarding the safe-handling protocols (LINK to Focus Area G).
3a As outlined in Activity 2, above, purchase R.C.W.
42.17.310(1)(ww) equipment necessary to safely R.C.W.
42.17.310(1)(ww) receive and handle incoming samples from unknown
sources.
3b Meet with architecture/engineering firms performing Central
Accessioning design service to ensure equipment is incorporated into
design.
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a Purchase orders, 02/2004
1b Protocol, 03/2004
1c Training class, 03/2004
2a Information collected, 02/2004
2b Meetings agendas, notes, 02/2004
2c Protocol, 03/2004
2d Training class, 03/2004
3a Purchase orders, Ongoing
3b Meeting agendas, notes, Ongoing
|
Responsible Parties: Identify the person(s) and/or entity assigned to
complete each task.
|
1a-3a ELS Office Director
3b Facility Planner
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
| By the end of 2003-04 grant period, the WAPHL will
have a BSL-2 laboratory facility available for processing clinical
specimens for chemical agents and will have a protocol for the
handling of specimens/samples with unknown toxicity. |
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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.
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Ensure that personnel hired to work on chemical terrorism
grant projects have obtained security clearances necessary for
compliance with Patriot Act of 2001.
2. As a part of the general WAPHL plan, ensure the upgrade of
laboratory security to meet current CDC standards for possession,
use and transfer of select agents (LINK TO Focus Area C).
|
Tasks: What key tasks will be conducted in carrying out each identified
strategy?
|
1a Following CDC requirements, ensure candidates being considered
for chemical terrorism positions are eligible for a security
clearance prior to receiving a job offer.
1b Document security clearance.
2a Identify CDC-recommended standards for laboratory security for
select agents.
2b Purchase equipment/supplies needed to meet CDC
required/recommended standards.
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a Job qualifications, Ongoing
1b Security clearance form, Ongoing
2a Current CDC standards, 09/2003
2b Purchase orders, 01/2004
|
Responsible Parties: Identify the person(s) and/or entity assigned to
complete each task.
|
1a Division ERP
1b Division ERP
2a WAPHL Operation Manager
2b WAPHL Operation Manager
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
| By the end of the 2003-04 grant period, the
laboratory will have policies and procedures on laboratory security,
the personnel will be trained on select agent security, and laboratory
security status will be evaluated annually. |
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 AREA C & E)
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Plan for PHL Laboratory Information Management System (LIMS)
conformity with APHL requirements document.
2. Participate in development of the WAPHL LIMS to ensure that
the needs of the Environmental Laboratory are met (LINK WITH FOCUS
AREA C and E).
3. Provide "need to know" accessibility within the LRN system for
access to current protocols, equipment, supplies, etc.
|
Tasks: What key tasks will be conducted in carrying out each identified
strategy?
|
1a Review APHL LIMS requirements
2a Work with WAPHL LIMS coordinator on components related to the
Chemistry Laboratory needs
3a Establish "need to know" accessibility requirements in
collaboration with CDC.
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a Requirements document, 09/2003
2a Meetings, notes, requirements, document, Ongoing
3a Requirements, document, 10/2003
|
Responsible Parties: Identify the person(s) and/or entity assigned to
complete each task.
|
1a PHL LIMS Coordinator
2a PHL LIMS Coordinator
3a PHL LIMS Coordinator
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
| By the end of the 2003-04 grant period, the LIMS
needs for the WAPHL Environmental Sciences Laboratory (ESL) will be
well defined and included in the LIMS development process. |
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|
