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Interim Progress Report - Budget Period Three
Critical Capacity: Implement a jurisdiction-wide program
to provide effective laboratory services in support of the
response to bioterrorism
Critical Capacity: Ensure adequate and secure
laboratory facilities, reagents, and equipment to rapidly detect and
correctly identify biological agents likely to be used in a bioterrorist
incident
Workplan - Budget Period Four
Critical Capacity 8: Provide effective laboratory
services in support of response to bioterrorism
1. Develop capability of Level A laboratories to
perform required testing and referral
2. Complete and implement an integrated
laboratory response plan
3. Address the identified needs for testing
food specimens for critical BT pathogens
4. Establish relationships with local HazMat teams, first responders, law enforcement
and FBI to provide laboratory support for their response to bioterrorism
5. Enhance relationships with hospital-based
laboratory practitioners, university laboratories, and infectious
disease physicians
6. Appoint a liaison from the state or
local LRN-member
laboratory to participate in meetings and conference calls relevant to LRN
operations and smallpox activities
Critical Capacity 9: Ensure adequate and secure laboratory
facilities, reagents, and equipment to rapidly detect and
correctly identify biological agents likely to be used in a bioterrorist
incident
1. Continue to develop or enhance
operational plans and protocols
2. Ensure capacity for LRN validated testing
for all Category A agents and other Level B/ C protocols as they are
approved
3. Ensure at least one public health
laboratory in your jurisdiction implements new advanced rapid
identification methods
4. Conduct at least one simulation exercise
per year
5. Ensure the availability of at least one
operational Biosafety Level 3 facility in your jurisdiction.
6. Ensure that laboratory registration,
operations, safety, and security are consistent with federal
requirements
7. Enhance electronic communications and LRN
electronic laboratory reporting
8. dentify the laboratories that have the
capacity for LRN-validated testing and reporting of smallpox through
human and environmental samples
Using the Interim Progress Report template below, provide a brief
status report that describes progress made toward achievement of each of
the critical capacities and critical benchmarks outlined in
the continuation guidance issued by CDC in February 2002. Applicants
should describe their agency’s overall success in achieving each critical
capacity. The progress report narratives should not exceed 1 page,
single-spaced, for each critical capacity. Applicants are welcome to use
bullet-point format in their answers, so long as the information is
clearly conveyed in the response.
CRITICAL CAPACITY: To develop and implement a jurisdiction-wide program
to provide rapid and effective laboratory services in support of the
response to bioterrorism, other infectious disease outbreaks, and other
public health threats and emergencies.
Provide an update on progress during Project Year III
toward achieving this critical capacity:
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During the 2002-03 Supplemental Bioterrorism Grant period,
the Washington Public Health Laboratories (WAPHL) made
significant progress toward goals established by HHS and CDC.
Overall, improvements were made in the establishment and
training of Level A/B laboratories, communication with first
responders, and in development of an integrated response plan
in Washington State for bioterrorism, other outbreaks of
infectious disease, and other public health threats and
emergencies. During the past twelve months, using funding
provided by HHS and CDC, the WAPHL made the following
improvements in its integrated plan for laboratory response to
bioterrorism:
1. The WAPHL prepared and followed a timeline for development
of a plan to improve working relationships and communication
between Level A (clinical) laboratories and Level B and C
Laboratory Response Network (LRN) laboratories in order to
ensure that Level A laboratories maintain core capability to:
perform rule-out testing on critical bioterrorism agents; safely
package and handle specimens; and refer to higher level
laboratories for further testing. WAPHL hired a Laboratory
Program Advisor and a Laboratory Information Management System (LIMS)
Coordinator to implement critical program activities. Lines of
communication were expanded through development of workgroups
with hospitals/laboratories, veterinarians, other state and
federal agencies (leading to formal cooperative agreements), and
the public health systems of other countries in the region.
2. The WAPHL made significant progress toward development of
an integrated response plan will direct Washington State
laboratories’ response to incidents of bioterrorism. Steps
included carefully defined roles and responsibilities, inter-
and intra-jurisdictional surge capacity, integration with other
department-wide emergency response efforts, protocols for safe
transport of specimens by air and ground, and improved/new lab
result protocols for local public health and law enforcement
agencies. Consolidated contracts with local health jurisdiction
laboratories have resulted in improved communication as well as
progress toward bringing these facilities up to full Level B
capability. Training aimed at improving the competency of Level
A/B laboratories to "Rule-out or Refer" and to safely ship
specimens has continued. In collaboration with Focus Area E,
progress has also been made toward establishment of secure
electronic linkages for reporting results in real-time.
3. The WAPHL has made limited progress in establishing
operational relationships with local members of HazMat teams,
first responders, and FBI to provide laboratory support for
their response to bioterrorism. Long-term plans call for
enhancement of these relationships through establishment of
designated points of contact, cross-training and/or joint
sponsorship of conferences. Unanticipated delays in hiring key
personnel have slowed progress in this area. There has, however,
been excellent progress toward training the WAPHL’s new
Laboratory Program Advisor and in the enhancement of WAPHL
management activities (such as specimen receipt, testing, and
reporting of laboratory data).
4. The WAPHL has made excellent progress toward enhancement
of relationships with community laboratory practitioners,
university laboratories, and infectious disease physicians
during the 2002-03 grant period. Recent collaborations have led
to opportunities to work with Clinical Laboratory Advisory
Council (CLAC) members and through this avenue improve the
region’s capability to deal with the possible reemergence of
smallpox. Also, WAPHL managers and staff have, with the
assistance of federal funding, been able to participate
regularly in infectious disease rounds and conferences and to
present findings concerning the assessment of molecular
methodologies for agents of bioterrorism.
5. The WAPHL has been successful in the development of
procedures and in training personnel to collect, process, and
transport blood and urine samples to CDC for analysis of both
chemical and biological agents. Plans for collection, processing
and transport of samples have been carefully reviewed and are
consistent with CDC-supplied protocols. Current procedures
ensure careful coordination will take place between CDC and the
WAPHL when specimens are to be forwarded for testing. The WAPHL
has also been successful in developing a database for tracking
and reporting of referred (including pass-through) specimens to
reference laboratories.
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Critical Benchmark #10: Has your state developed a plan to improve
working relationships and communication between Level A (clinical)
laboratories and Level B/C Laboratory Response Network labs to ensure
Level A core capabilities (perform rule-out testing on critical BT
agents, safely package and handle specimens, refer to higher level
(B/C) labs for further testing) ?
DOH Response: YES
CRITICAL CAPACITY: As a member of the Laboratory Response
Network (LRN), to ensure adequate and secure laboratory
facilities, reagents, and equipment to rapidly detect and
correctly identify biological agents likely to be used in a
bioterrorist incident.
Provide an update on progress during Project Year III
toward achieving this critical capacity:
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1. The WAPHL successfully developed operational plans and
protocols that provide safe transportation of samples, improved
safety, enhanced triage capabilities, and updated procedures for
handling bioterrorism agents during the past year. Equipment has
been purchased and installed that has significantly improved the
safety of laboratory personnel as well as the security of select
agents. Using CDC funding, the WAPHL hired qualified personnel
to carry out key bioterrorism-related testing and reporting
activities. State and local public health staff were trained in
the use of updated LRN protocols as the CDC approved them. This
has helped the WAPHL to maintain an adequate number of trained
staff to handle public health emergencies. In the 2003-04
Bioterrorism Response Grant period, the WAPHL is requesting
additional CDC support in the form of a qualified trainer
capable of working directly with local health jurisdictions,
first responders, the FBI and other key emergency response
personnel to thoroughly train/update them on current
laboratory-related protocols and to help create a seamless
bioterrorism response and infectious disease surveillance
network in Washington State. Recent experience in emergency
response coordination efforts has clearly demonstrated the need
for such a trainer to strengthen the critical link between first
responders and the WAPHL. The WAPHL
Safety and Quality Control Coordinator has revised and updated
laboratory protocols (i.e., risk assessment, employee
competency, test validation, proficiency testing, etc) to ensure
the appropriate documentation of laboratory operations.
2. The WAPHL has continued to work to ensure that public
health capacity exists for LRN-validated testing by carefully
monitoring the LRN website for updated protocols and obtaining
the necessary equipment, supplies and reagents to maintain and
improve readiness. In the past year, for example, the WAPHL has
purchased state of the art equipment such as a real-time PCR
Smart-Cycler system, an automated nucleic acid purification
instrument (MagNA Pure) and an automated DNA Sequencer R.C.W.
42.17.310(1)(ww), in order to maintain readiness and provide
test results that are as close to real-time as possible. The
purchase of additional state-of-the-art laboratory equipment
through CDC funding resources has also allowed the WAPHL to
expand its list of available test methods to include additional
bioterrorism-related microorganisms, bio-toxins and chemicals.
Overall, improvements in preparedness and response to
bioterrorism have significantly increased the efficiency of
routine diagnosis, surveillance and epidemiologic
investigations. The focus on methods development, using
amplification techniques with real-time PCR and direct probes,
has been successful as a result of mutual collaborations with
the University of Washington in Seattle. For example,
significant progress has been made in the past year in the
development of Fluorescent in-situ Hybridization (FISH)
technology targeting systemic diseases (tularemia, brucellosis,
yersiniosis, reckettsiosis) and diseases of the respiratory
tract (pulmonary anthrax, Q-fever, coccidiomycosis, etc.).
3. Through the use of state consolidated contracts with local
health jurisdiction laboratories in both eastern and western
Washington, the WAPHL has worked to ensure that public health
support laboratories have appropriate instrumentation and
appropriately trained staff to provide necessary surge capacity
for bioterrorism response and other public health emergencies.
The Washington State Department of Health (DOH) has also
developed plans to further expand the number of laboratories in
the state capable of providing Level B LRN support. In
collaboration with the CDC, expanded foodborne disease testing
protocols are being established to include botulism, etc., in
food and water. Testing algorithms have also been established
for use with updated protocols at the WAPHL.
4. The WAPHL was able to conduct/participate in bioterrorism
simulation exercises in the past year in preparation for a
possible bioterrorism-related event. Overall, the results of
simulation exercises have been encouraging and have allowed
WAPHL management and staff to identify improvements that will be
necessary for a truly seamless emergency response system.
Through CDC funding provided for the strengthening of the public
health response to bioterrorism, other infectious disease
outbreaks, and other public health threats and emergencies, the
WAPHL has formulated plans to strengthen what are clearly vital
links between first responders, local and state public health,
and federal agencies. An assessment was also made of the
bioterrorism-related proficiency testing materials available to
LRN laboratories in Washington State. Thanks to proactive
efforts by the CDC, regular proficiency challenge samples are
routinely available for LRN approved test methods. WAPHL is
actively involved in this quality assurance program. The WAPHL
is also participating in bioterrorism-related proficiency
testing available through the College of American Pathologists
(CAP) and strongly encourages all certified LRN laboratories in
the state to participate as well.
5. The WAPHL has been working diligently to ensure that
additional Bio-Safety Level 3 (BSL-3) facilities are available
for surge capacity. [Text has
been omitted for security reasons as provided in R.C.W. 42.17.310(1)(ww)] These
facilities are in the process of being evaluated to ensure that
they meet standards established for safe practices in the CDC-NIH
Biosafety in Microbiological and Biomedical Laboratories (BMBL)
manual, 4th Edition. Steps are also being taken to
evaluate and enhance protocols that will allow existing BSL-2
facilities to follow BSL-3 practices as outlined in the BMBL
manual.
6. The WAPHL has been very active in upgrading laboratory
security and safety to make it consistent with recommendations
established in the BMBL manual (and updates). This has included
the use of consultants for improvement of laboratory security as
well as specialists in laboratory safety. Bioterrorism grant
funding provided through the CDC has been used directly to
upgrade the laboratory facility. Additional work has also been
accomplished in the retrofitting of the WAPHL facility to
withstand local seismic activity. Through funding provided by
the Bioterrorism Response Grant, the development of a laboratory
information management system (LIMS) is also moving forward
through direct WAPHL involvement in an (Association of Public
Health Laboratories) APHL sponsored project to identify business
process requirements for public health laboratory LIMS.
Additional work is planned, in cooperation with the APHL, for
implementation of a LIMS at the WAPHL through a collaborative
development project.
7. In cooperation with Focus Area E (Health Alert
Network/Communications and Information Technology) the WAPHL is
involved in the enhancement of electronic communications within
the LRN through purchase of high-speed equipment, implementation
of the National Electronic Disease Surveillance System (NEDSS),
upgrade of the Spokane regional Health Department (SRHD)
Laboratory, and a database of both private and public health
laboratories. The WAPHL has upgraded computer hardware in the
laboratory in order to ensure reliable high-speed connection.
Improvements in electronic communications, coordinated by the
CDC, now support proficiency testing programs that allow
multicenter validation studies.
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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 #8: To develop and implement a
jurisdiction-wide program to provide rapid and effective
laboratory services in support of the response to bioterrorism,
other infectious disease outbreaks, and other public health
threats and emergencies.
Recipient Activities:
Develop and maintain the capability of Level A (sentinel)
laboratories to (a) perform rule-out testing on critical BT
agents, (b) safely package and handle specimens, and (c) refer to LRN Level B/C (reference/confirmatory) laboratories for further
testing. (LINK WITH FOCUS AREAS D AND G AND HRSA PRIORITY AREA #4)
- Strategies: What overarching approach(es) will be used to undertake
this activity?
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1. Increase funding to include an additional Laboratory
Program Advisor (LPA) for focus on communication and
coordination between WAPHL and sentinel laboratories to ensure
the pursuit, organization, management, and accomplishment of
program activities
2. Maintain funding for LIMS Coordinator to continue
development on interoperable LIMS
3. Maintain lines of communication with Level A Laboratories
(ELaborations, Training, etc)
4. Survey analytical (clinical and environmental; chemical
and biological; veterinary; public, private and academic)
laboratories regarding emergency response (FOCUS AREA D AND HRSA
LINK)
5. Continue plan for training of Level A laboratories - Link
with plan to collect laboratory-specific emergency response
information (Link to Focus area G)
6. Revise and update database of Washington’s Level A/B
laboratories
7. Coordinate hospital laboratory activities and
infrastructure (e.g., staff travel) funded through the HRSA
Cooperative Agreement
8. Work with Level A/B labs to meet shipping guidelines for
specified Department of Transportation and International Air
Transport Association (IATA) shipping regulations (HRSA funding)
9. Assess sentinel laboratories for safe practices
10. Produce training website for on-line registration
and distribution of training materials and information regarding
LRN response to bioterrorism-related issues. (Link to focus area
G)
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Tasks: What key tasks will be conducted in carrying out each
identified strategy?
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1a Support travel of LPA to local, regional and national
meetings/conferences
1b Support training and travel in the APHL Incident Command
System (see APHL Guidance, p 34).
1c Travel for Level A/B planning/training funded through HRSA
1d Hire second LPA
1e Travel for packaging and shipping training
1f Purchase equipment/supplies to support FTE
2a Participate in APHL conference calls
2b Attend APHL meetings for coordination of LIMS development
2c Evaluate collaborative vendor purchase and development
options
3a Develop R.C.W. 42.17.310(1)(ww) uniform protocols for
screening and collecting Bioterrorism specimens and specimen
triage to ensure that only properly screened, appropriate
specimens are submitted to the WAPHL for testing.
3b Present to LHJs (including surveillance and Epi-response
staff, and health officers), HazMat teams and EOC uniform
protocols for screening and collection of bBioterrorism
specimens and specimen triage to ensure that only properly
screened and appropriate specimens are submitted to the WAPHL
for testing.
3c Develop a written integrated lab response plan for
bioterrorism to sentinel labs that includes input from sentinel
laboratories, LHJs, Epidemiology and the CDC.
3d Distribute a written integrated lab response plan for
bioterrorism to sentinel labs
3e Establish and enhance lines of communication with sentinel
laboratories through site visits and regional meetings
3f Encourage proficiency testing by sentinel labs
4a Develop survey with CDC collaboration
4b Administer survey and analyze data
4c Use survey results in bioterrorism planning
5a Review survey of analytical labs and update training plan
5b Identify laboratories in need of training
5c Schedule training for Level A labs
6 Update database to include all analytical laboratories in
region
7a Notify Level A hospital laboratories of travel funding
through HRSA for training
7b Provide bioterrorism funding to hospital labs for
proficiency testing through HRSA
7c Notify hospital labs of funding available through HRSA for
DOT & IATA-approved shipping containers
8a Purchase shipping containers that meet current regulations
for non-hospital laboratories
8b Distribute shipping containers to non-hospital labs
9a Include questions about safe practices in analytical lab
survey
9b Include training in safe practices in Level A training
10a Contract for web design and build
10b Implement and maintain web page
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Timeline: What are the critical milestones and completion dates for
each task?
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1a Ongoing
1b 4/2004
1c 11/2003
2/2004
5/2004
8/2004
1d 10/03
1e 11/2003
2/2004
5/2004
8/2004
1f 10/03
2a-b Ongoing
2c 12/2003
3a 12/03
3b 2/04
5/04
8/04
3c 10/03
3d 2/04
5/04
8/04
3e-f Ongoing
4a 12/03
4b 1/04
4c 6/04
5a-b 2/4
5c 2/04
6 Ongoing
7a 12/03
7b 10/03
7c 10/03
8a-b Ongoing
9a 12/03
9b 2/04
5/04
8/04
10a 7/04
10b Ongoing
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Responsible Parties: Identify the person(s) and/or entity assigned
to complete each task.
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1a LPA
1b Bioterrorism Coordinator
1c LPA
1d Operations Manager
1e LPA
1f Operations Manager
2a-c Bioterrorism Coordinator
3a Micro OD
3b LPA
3c Div ERP
3d-f LPA
4a-b Training Manager
4c LPA
5a-c LPA
6 Training Manager
7a LPA
7b LQA
7c LQA
8a-b Operations Manager
9a Training Manager
9b LPA
10a Operations Manager
10b LIMS Coordinator |
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
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1a-b Meeting attendance
1c Training documents
1d Employment acceptance
1e Training documents
1f Purchase order
2a-b Notes
2c Meeting notes & documents
3a Published protocols
3b Class attendance
3c Published Plan
3d Class attendance
3e Meeting attendance
3f Training plan
4a-b Survey
4c Survey data
5a Survey data
5b Training courses
5c Class schedule
6 Database
7a Meeting attendance
7b-c ELaborations Article
8a Purchase orders
8b Incoming samples
9a Survey
9b Training Materials
10a-b Website
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- CRITICAL BENCHMARK #12: Complete and implement an
integrated response plan that directs how public health,
hospital-based, food testing, veterinary, and environmental
testing laboratories will respond to a bioterrorism incident, to
include: (a) roles and responsibilities; (b) inter- and
intrajurisdictional surge capacity; (c) how the plan integrates
with other department-wide emergency response efforts; (d)
protocols for safe transport of specimens by air and ground; and
(e) how lab results will be reported and shared with local public
health and law enforcement agencies, ideally through electronic
means. (LINK WITH FOCUS AREAS A, B, D, E AND F, and CROSS CUTTING
ACTIVITY LABORATORY CONNECTIVITY, Attachment X)
Strategies: What overarching approach(es) will be used to undertake
this activity?
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1. Finalize/update bioterrorism response protocols with
Epidemiology and integrate with other department-wide emergency
response efforts (include public health, hospital-based, food
testing, veterinary, and environmental testing)
2. Continue development of Memoranda of Understanding (MOU)
with reference laboratories (Surge Capacity) to include food
testing, veterinary, and environmental testing
3. Update training manual for Level A laboratories' roles and
responsibilities and distribute
(Link to focus area G)
4. Update protocols used for triage and specimen collection.
5. Update and distribute protocols for safe transport of
specimens.
6. Define and publish turn-around times (TAT) in training
manual and Elaborations
(Link to focus area G)
7. Update reporting protocols to specify how lab results will
be reported and shared with Epidemiology, local public health
and law enforcement agencies
8. Purchase equipment to communicate with stakeholders (APHL
guide)
9. Collaborate with the Washington Animal Diseases Diagnostic
Laboratory (WADDL) to prepare for and respond to acts of
bioterrorism or to other public health emergencies. This
includes establishing RCW 42.17.310(1)(ww) and supporting
laboratory capacity for sentinel animal disease surveillance;
providing veterinary diagnostic laboratory support in meeting
the counter-terrorism mission of the state public health
department; providing WADDL with support to enhance capability
to diagnose overlap agents in animals, food, and low risk
environmental samples; and supporting laboratory capacity for
diagnosis of an intentionally introduced agent in animals (Link
with Focus area B).
10. The WAPHL will, in consultation with the CDC and other
federal/state agencies, compile a region-wide inventory of all
analytical laboratories through a comprehensive survey. In this
survey, the WAPHL will assess the current capabilities and
capacities of laboratories in the region as well as their
current capabilities and needs related to "peri-" and "post-"
event involvement in emergency response activities. This survey
will be administered to public and private food testing
laboratories, veterinary laboratories, environmental testing
laboratories, hospital/clinical laboratories (including academic
health centers), regional/local public health laboratories,
public health laboratories of countries and states that share
our borders, etc. These are laboratories that could potentially
play an important role in helping public health officials
respond to biological and/or chemical acts of terrorism or other
public health emergencies. A summary of survey data will be
compiled and a database of regional laboratory capabilities will
be developed. (LINK BETWEEN FOCUS AREAS A, B, C, D, E, F, G AND
HRSA PRIORITY AREA #4, Cross-cutting Benchmark #3)
11. The WAPHL will, as part of the comprehensive survey
mentioned above, determine what formal and informal cooperative
agreements currently exist in and among laboratories (both
public and private) in the region. (LINK BETWEEN FOCUS AREAS C
AND D)
12. The WAPHL will consider the results of this needs
assessment survey when planning and implementing enhancements to
the public health infrastructure of the state. (LINK BETWEEN
FOCUS AREAS C AND D)
13. The WAPHL will consider the results of this needs
assessment survey when implementing new or improved cooperative
agreements between laboratories in the region. (LINK BETWEEN
FOCUS AREAS C AND D)
14. The WAPHL will integrate new advanced rapid
identification methods approved by the LRN into the current
laboratory-testing algorithm for human, environmental, animal or
food specimens. (LINKS BETWEEN FOCUS AREAS B, C AND D)
15. The WAPHL, in collaboration with cooperating partners
(including hospital laboratories), will conduct a simulation
exercise involving at least one biological and chemical threat
agent that specifically tests laboratory readiness and
capability to perform specimen threat assessment, intake
prioritization, testing, confirmation, and results reporting
using the LRN website. (LINK BETWEEN FOCUS AREAS A, C, D AND G)
16. The WAPHL will ensure that laboratory registration,
operations, safety, and security are consistent, at a minimum,
with the requirements set forth in Select Agent Regulation (42
CFR 73) and the Patriot Act of 2001. (LINK BETWEEN FOCUS AREAS C
AND D)
17. The WAPHL will enhance electronic communications and
Washington Electronic Disease Surveillance System (WEDSS)
reporting to enable integration with LRN plans (Including the
use of LOINC codes for the reporting of test results). (LINK
BETWEEN FOCUS AREAS C, D AND E, and HRSA Priority Area #4,
Cross-cutting Benchmark #4)
18. The WAPHL will work on pre-event smallpox planning
and coordination to identify laboratories that have the capacity
for LRN-validated testing and reporting of Variola major,
Vaccinia and Varicella through human and environmental samples.
This collaboration also includes review of established smallpox
emergency procedures and specimen collection supplies. (LINK
BETWEEN FOCUS AREAS B AND C)
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Tasks: What key tasks will be conducted in carrying out each
identified strategy?
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1a Attend 50 state Focus Area C/D Conference in late 2003
(request travel)
1b Evaluate the National Laboratory Database of key partners
developed by DLS/PHPPO
1c Review and update PHL protocols in cooperation with CDC
and EHSPHL to ensure integration
2a Update existing MOUs as needed
2b Complete implementation of MOUs
3a Review analytical lab survey data
3b Update training manual using survey summary data
4 Update protocols in collaboration with EHSPHL (LINK TO
FOCUS B)
5a Update safe transport protocols
5b Distribute protocols to Level A/B labs
6a Update and publish Turn-Around Times (TAT)
6b Schedule publication of TATs in Elaborations and
website
7a Update reporting protocols (including back-up reporting
systems) to conform with CDC recommendations
7b Publish reporting protocols
7c Include reporting protocols in training manual
8a Evaluate equipment needs for required communication
8b Purchase communication equipment
9a In conjunction with Focus area B activities, assess
capacity and develop strategies for initiating R.C.W.
42.17.310(1)(ww) sentinel zoonotic disease surveillance in
animals to enhance early detection of public health threats and
bioterrorism events.
9b WADDL will, in collaboration with DOH, identify and
prioritize R.C.W. 42.17.310(1)(ww) zoonotic agents of concern
for sentinel animal disease surveillance.
9c WADDL will establish R.C.W. 42.17.310(1)(ww) enhanced
laboratory capacity for diagnosis of the prioritized agents in
cooperation with WAPHL.
9d WADDL will hire and train a microbiologist to perform
assays as requested by DOH
9e WADDL will provide capacity to perform necropsy and
histopathology on animals that die of unusual disease.
10a Consult with the CDC and other federal/state agencies on
development of inventory of analytical laboratories
10b Develop survey
10c Administer survey
10d Analyze/summarize survey
11a Summarize existing cooperative agreements
11b Use summary in development of WAPHL plans for LRN
12 Use survey results in development of plans
13 Use survey summary in planning for cooperative agreements
14a Identify new approved methods on the LRN website
14b Implement methods and integrate into current laboratory
testing algorithm
15a Plan cooperative exercise with partners
15b Participate in simulation exercise
15c Summarize cooperative exercise with partners
15d Implement suggested changes
16a Review Select Agent Regulation (42 CFR 73) and the Patriot
Act of 2001
16b Update laboratory registration, operations, safety, and
security as required
17 Ensure WAPHL LIMS development integrates with LRN and APHL
plans
18a Ensure survey of analytical laboratories identifies
capacities for smallpox testing and referral
18b Review and update smallpox emergency procedures and
potential needs for specimen collection supplies
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Timeline: What are the critical milestones and completion dates for
each task?
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1a 10/03
1b 12/03
1c Ongoing
2a 12/03
2b 8/04
3a-b 3/03
4 10/03
5a-b 10/03
6a Biannual
6b As needed
7a-b 12/03
7c 1/04
8a-b 12/03
9a 2/04
9b 12/03
9c 2/ 04
9d 2/04
9e 12/03
10a-b 12/03
10c 1/04
10d 6/04
11a 12/03
11b 4/04
12 6/04
13 6/04
14a-b Ongoing
15a Ongoing
15b-d 8/04
16a 9/03
16b 12/03
17 Ongoing
18a 12/03
18b Ongoing
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Responsible Parties: Identify the person(s) and/or entity assigned
to complete each task.
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1a Director DOH Office of Environmental Sciences and Director
Office of Public Health Microbiology (Micro)
1b LIMS Coordinator
1c Div ERP
2a-b PHL Dir
3a-b Training Manager
4 Micro Office Director
5a Micro Office Director
5b LPA
6a-b Micro Office Director
7a-b Micro Office Director
7c LPA
8a-b LIMS Coordinator
9a-e WADDL
10a-d Training Manager
11a-b Micro Office Director
12 Training Manager
13 Micro Office Director
14a-b Micro Office Director
15a Div ERP
15b-c PHL Director
15d Ops Manager
16a-b Div ERP
17 LIMS Coordinator
18a Training Manager
18b Ongoing
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
|
1a Travel documentation
1b Database evaluation
1c Updated protocols
2a-b Finalized MOUs
3a-b Updated manual
3b Updated manual
4 Updated protocols
5a-b Updated protocols
6a Updated TAT
6b Publication
7a-c Updated protocol
8a Equipment list
8b Purchase orders
9a Assessment done
9b Priorities listed
9c Tests identified
9d FTE filled
9e Necropsy reports
10a Inventory
10b-c Survey
10d Survey summary
11a Summary
11b WAPHL Plans
12 WAPHL plans
13 Survey summary
14a Methods
14b Testing algorithm
15a-b Plan
15c Exercise summary
15d List of changes
16a Regulations
16b Plan for upgrade
17 LIMS Development plan
18a Survey
18b Review document
|
Back to top
- In accord with Critical Benchmark #12, address the
identified needs for testing food specimens for critical BT
pathogens. This may be done by contracting for services with
laboratories that possess the requisite capabilities, by
sponsoring such capability development within collaborating
organizations (such as 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 is available through FDA, in
consultation with CDC (see Appendix 1 for FDA contact
information).
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Continue collaborations with FDA Bothell for surge
capacity through MOU and cross training program (Link to focus
area G)
2. Compile/Update food testing protocols for bioterrorism
specimens
3. Continue development of analytical methods used for
bioterrorism testing and coordinate with analytic methods used
by FDA (in consultation with CDC)
4. Continue collaborations with WA Dept of Ag in Olympia and
Yakima through MOU
5. Implement BotTox ELISA assay - equipment and reagents from
CDC
|
Tasks: What key tasks will be conducted in carrying out each
identified strategy?
|
1a Finalize FDA MOU
1b Continue cross training with FDA staff
1c Share necessary protocols with FDA
2a Evaluate need for food testing protocols
2b Update food testing protocols to meet CDC and FDA
requirements
2c Distribute food testing protocols as needed
3a Update food testing protocols to meet CDC and FDA
requirements
3b Purchase equipment for implementation of food testing
protocols
4 Establish MOU with WA Dept of Agriculture laboratories
5 Perform BotTox ELISA cross-training at PHL
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a 12/03
1b-c Ongoing
2a 10/03
2b 12/03
2c 1/04
3a 12/03
3b 1/04
4 12/03
5 9/03
|
Responsible Parties: Identify the person(s) and/or entity assigned
to complete each task.
|
1a PHL Dir
1b-1c Micro OD
2a-3b Env OD
4 PHL Dir
5 Micro OD
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
|
1a Completed MOU
1b Completed cross-training
1c Completed protocols
2a List of protocols
2b-c Completed protocols
3a Completed protocols
3b Purchase orders
4 Completed MOU
5 Training attendance
|
Back to top
- Establish and maintain operational relationships with local
members of HazMat teams, first responders, local law enforcement
and FBI to provide laboratory support for their response to bioterrorism, including environmental testing for exposure
assessment and chain-of-custody procedures. Examples of enhanced
these relationships include designated points of contact,
cross-training in each discipline, and/or joint sponsorship of
conferences. (LINK WITH FOCUS AREA D)
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Update and finalize database of first responder points of
contact.
2. Expand the plan for training and collaboration with first
responders. Enhance relationships by conducting regional
meetings/conferences with HazMat teams, local law enforcement
agencies and other first responders. Ensure first responders as
well as regional and local public health are involved in
training and collaboration (Link to focus area G)
3. Continue planning and implementation of PHL Central
Receiving.
4. Plan and hold meeting with key partners to discuss plans
during periods of increased activity.
|
Tasks: What key tasks will be conducted in carrying out each
identified strategy?
|
1 Update/maintain database to include all first responder
groups in WA
2a Plan meetings with first responder groups
2b Identify training contacts of first responders and
implement a train-the-trainer program.
3a Identify next steps for planning of Central Receiving
Facility
3b Contract AE firm for design
3c Identify capital improvement and equipment needs
3d Determine staffing needs for Central Receiving Facility
4a Identify partners necessary for effective planning
4b Schedule meeting with key partners
4c Implement findings/updated plans
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1 8/03
2a 10/03
2b 1/04
3a 9/03
3b 11/03
3c 1/04
3d 5/04
4a 10/03
4b 1/04
4c 8/04
|
Responsible Parties: Identify the person(s) and/or entity assigned
to complete each task.
|
1 Training Manager
2a-b LPA
3a-d Operations Manager
4a-c Div ERP
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
|
1 Database
2a Meeting agendas
2b Training schedule
3a Plans
3b Contract
3c Equipment List
3d Needs List
4a List of partners
4b Agenda
4c Plans
|
- Enhance relationships with hospital-based laboratory
practitioners, university laboratories, and infectious disease
physicians through participation in infectious disease rounds and
conferences. (LINK WITH FOCUS AREA D)
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Continue development of secure web-based bioterrorism
information for Level A/B LRN laboratories in Washington
2. Continue outreach to professional organizations/agencies
using innovative electronic communication systems.
3. Develop/expand general bioterrorism
guidelines for response to bioterrorism events
4. Continue to publish and distribute articles in periodicals
such as the Elaborations newsletter in order to provide
pertinent information to LRN laboratories
5. Update current list of professional organizations and
laboratory groups for use in identifying conferences (local and
national).
6. Continue methods development and present findings at
national/ international conferences
7. Attend meetings and seminars such as "Show and Tell" and
"grand rounds" at area laboratories and hospitals.
|
Tasks: What key tasks will be conducted in carrying out each
identified strategy?
|
1a Contract for web design and build (LINK WITH FOCUS AREA E)
1b Implement and maintain web page (LINK WITH FOCUS AREA E)
2a Attend BT-related conferences
2b Plan meetings to discuss BT-related issues with
professional organizations
3a Review existing guidelines
3b Develop/expand guidelines as needed
4a Include BT-related subjects in Elaborations
publications
4b Provide funding for publication of ELaborations
5a Formalize current list of organizations/groups and update
5b Join appropriate organizations and attend meetings
6a Schedule attendance at conferences
6b Prepare and present current information on methods
development
7a Obtain schedules of hospital seminars
7b Schedule attendance at seminars |
Timeline: What are the critical milestones and completion dates for
each task?
|
1a-b Ongoing
2a-b Ongoing
3a 10/03
3b 11/03
4a Bimonthly
4b 9/03
5a 12/03
5b 1/04
6a-b Ongoing
7a-b 9/03
|
Responsible Parties: Identify the person(s) and/or entity assigned
to complete each task.
|
1a-b LIMS Coordinator
2a-b PHL Dir
3a-b Micro OD
4a LPA
4b LQA
5a QA/QC Coordinator
5b PHL Dir
6a PHL Dir
6b Micro OD
7a-b PHL Dir
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
|
1a Design
1b Web page
2a Conference List
2b Agendas
3a List of guidelines
3b Updated Guidelines
4a Articles
4b Publications
5a List
5b Membership
6a List of Conferences
6b Presentations
7a Schedules
7b Schedules |
- (Smallpox) Appoint a liaison from the state or local LRN-member
laboratory to participate in meetings and conference calls with
smallpox steering committee, stakeholders, and any other
activities relevant to LRN operations and smallpox activities.
Back to top
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Appoint liaison from the state or local LRN-member
laboratory to participate in meetings and conference calls
2. Expand collaborations with State Emergency Response
Coordinators (SERCs) and Regional Emergency Response
Coordinators (RERCs)
for strengthening of WA Smallpox response plans. (Link to focus
area G)
|
Tasks: What key tasks will be conducted in carrying out each
identified strategy?
|
1a Identify candidates for liaison
1b Appoint/request candidate’s participation
2a Contact SERCs and RERCs and schedule meetings to discuss
collaborations
2b Implement plans resulting from collaborative meetings
|
Timeline: What are the critical milestones and completion dates for
each task?
Responsible Parties: Identify the person(s) and/or entity assigned
to complete each task.
|
1a-b PHL Dir
2a-b PHL Dir
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
|
1a List of candidates
1b Appointment letter
2a Meeting schedules
2b Plans
|
Back to top
CRITICAL CAPACITY #9: As a member of the Laboratory Response
Network (LRN), to ensure adequate and secure laboratory
facilities, reagents, and equipment to rapidly detect and
correctly identify biological agents likely to be used in a
bioterrorist incident.
Recipient Activities:
- Continue to develop or enhance operational plans and
protocols that include: (a) specimen/samples transport and
handling; (b) worker safety; (c) appropriate Biosafety Level (BSL)
working conditions for each threat agent; (d) staffing and
training of personnel; (e) quality control and assurance; (f)
adherence to laboratory methods and protocols; (g) proficiency
testing to include routine practicing of LRN validated assays as
well as participation in the LRN’s proficiency testing program
electronically through the LRN website; (h) threat assessment in
collaboration with local law enforcement and FBI to include
screening for radiological, explosive and chemical risk of
specimens; (i) intake and testing prioritization; (j) secure
storage of critical agents; and (k) appropriate levels of supplies
and equipment needed to respond to bioterrorism events with a
strong emphasis on surge capacities needed to effectively respond
to a bioterrorism incident. (LINK WITH FOCUS AREA D)
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Enhance established protocols for specimen transport and
handling using current guidelines (i.e., DOT and IATA).
2. Expand risk assessment operations to include all
BT-related protocols used by the PHL.
3. Review and update appropriate BSL protocols to ensure safe
working conditions for each threat agent.
4. Expand staffing and training to ensure adequate levels of
routine and emergency testing and safety (Link to focus area G)
5. Continue to develop plans and protocols that include CDC
recommended QA/QC for bioterrorism
6. Ensure adherence to LRN developed protocols
7. Ensure proficiency testing, including CDC validation
studies, PHL competency reviews and CAP bioterrorism
proficiencies are up to date.
8. Ensure threat assessments for radiological, explosive and
chemical risks are current for biological specimens submitted
for analysis
9. Review and update specimen triage with Epidemiology
10. Continue plans for secure storage of critical agents
11. Develop a written protocol to ensure appropriate levels
of supplies and equipment for bioterrorism events (consider need
for surge capacity)
12. Purchase equipment and supplies to assure personnel
safety, including biosafety cabinets, other biocontainment
measures, signage, lockable freezers-refrigerators and
incubators, personal protective equipment (PPE) including, PAPRS,
N-95 masks, etc
13. Hire additional qualified personnel necessary to use
sophisticated instrumentation and other staff necessary to carry
out the key BT, related activities (e.g., state lab training
coordinator, information technology staff, etc.) of the state
public health laboratory.
14. Purchase equipment and supplies needed to respond to
infectious disease outbreaks or bioterrorism events.
15. Schedule staff to travel to appropriate bioterrorism
courses in laboratory confirmatory (reference) methods and
related programs sponsored or co-sponsored by CDC, the NLTN, FDA
and/or FSIS (Link to focus area G)
16. Schedule travel and registration fees for staff to attend
important conferences, such as the International Conference on
Emerging Infectious Diseases, and the annual meeting of the
American Society for Microbiology. (Link to focus area G)
|
Tasks: What key tasks will be conducted in carrying out each
identified strategy?
|
1a Review updated and current guidelines (i.e., DOT and IATA).
1b Update and obtain signatures on updated protocols
1c The PHL Integrated Standards and Security Management (ISSM)
Committee will review current protocols and recommend
enhancement/change based on DOT and IATA guidelines.
1d If the ISSM Committee identifies changes in current
protocols, such changes will be reviewed by PHL management for
cost effectiveness and impact.
1e If changes are authorized, training will be developed and
implemented on new/revised protocols
2a Identify protocols needing assessment
2b Perform necessary assessments
2c Bioterrorism protocols will undergo a risk assessment and
evaluation prior to implementation
2d The Safety Officer, in conjunction with the RO, will
develop and implement risk assessments specific to the
bioterrorism protocols.
2e The PHL ISSM Committee will review bioterrorism protocols,
risk assessments, etc and give approval if acceptable prior to
implementation
3a Review BSL protocols
3b Update protocols and obtain signatures
3c The PHL ISSM Committee will recommend changes to current
bioterrorism BSL protocols and recommend changes based on BMBL
guidelines
3d If the ISSM Committee identifies changes in current
protocols, review by PHL management for cost effectiveness and
impact.
3e If changes are authorized, training will be developed and
implemented on new/revised protocols
4a Identify staffing needs through an evaluation of test
volumes, expansion plans, risk assessments, etc.
4b Hire and/or train additional staff
4c Purchase equipment/supplies to support FTE
5 Review PHL protocols for bioterrorism to ensure CDC
recommended QA/QC is followed
6 Review and update competency of bioterrorism staff
7 Review proficiency results to ensure results are up to date
8a Collaborate with local law enforcement and FBI to identify
protocol for threat assessment
8b Develop training strategy
8c Train law enforcement and FBI in updated protocols
9a Review current triage protocol with Epi
9b Update protocol to meet current needs
10a Develop and adopt inventory procedures
10b Implement consultant recommendations for physical
security
11a. Maintain inventory of shipping supplies sufficient to
meet surge capacity needs
11b. Maintain inventory of testing supplies sufficient to
meet surge capacity needs
11c Identify equipment used for bioterrorism requiring
maintenance contracts
12a Identify PPE and other equipment recommended for personal
safety
12b Purchase necessary equipment
13a Continue funding for Laboratory Program Advisor (LPA)
13b Funding for second LPA
13c Open register, interview and select qualified
Microbiologist III
14 In collaboration with CDC, identify and purchase
equipment/supplies required for (a) response to infectious
disease outbreaks or bioterrorism events and (b) monitoring of
laboratory equipment
15 Identify courses and schedule attendance of bioterrorism
response staff to maintain required proficiency
16a Identify conferences and schedule attendance of
bioterrorism response staff
16b Prepare talks on methods development related to
bioterrorism response for presentation at conferences
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a-e Ongoing
2a-e Ongoing
3a-e Ongoing
4a Done
4b 10/03
4c 10/03
5 12/03
6 Ongoing
7 9/03
8a-b 1/04
9a-b 9/03
10a 10/03
10b 12/03
11a-b Done
11c 10/03
12a 9/03
12b 1/04
13a-b 10/03
13c 9/03
14 10/03
15 9/03
16a 12/03
16b Ongoing
|
Responsible Parties: Identify the person(s) and/or entity assigned
to complete each task.
|
1a-b Micro OD
1c Div ERP
1d Div ERP
1e Safety Officer
2a-e Div ERP
3a-d Div ERP
3e Safety Officer
4a PHL Dir
4b Micro OD
4c Micro OD
5 QA/QC Coordinator
6 Micro OD
7 Micro OD
8a-c LPA
9a-b Micro OD
10a Div ERP
10b Operations Manager
11a Operations Manager
11b Micro OD
11c Operations Manager
12a-b Safety Officer
13a-b Operations Manager
13c Micro OD
14 Micro OD
15 Micro OD
16a Micro OD
16b PHL Dir
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
|
1a Updated guidelines
1b Updated protocols
1c List of protocols
1d Updated protocols
1e Training plans
2a List of protocols
2b-d Assessment documentation
2e Revised protocols
3a List of protocols
3b Revised protocols
3c Changes
3d Reviewed protocols
3e Training plan
4a Needs list
4b Employment offer
4c Purchase orders
5 Updated protocol
6 Competency documentation
7 Review documentation
8a List of collaborators
8b Training plan
8c Training schedule
9a Suggested changes
9b Updated protocol
10a Procedures
10b Consultant contract
11a-b Inventory
11c List of equipment
12a Equipment list
12b Purchase order
13a-c Job offer
14 Purchase orders
15 Schedule
16a Schedule
16b Prepared talks |
- CRITICAL BENCHMARK #13: Ensure capacity exists for LRN
validated testing for all Category A agents and other Level B/ C
protocols as they are approved.
Back to top
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Review PHL capacity for testing of all Category A
bioterrorism agents.
2. Finalize/update MOUs with regional LRN Level B & C
laboratories to ensure adequate capacity
3. Regularly update/validate LRN protocols from the LRN
website.
4. Fill and train Microbiologist III position to perform LRN
validated procedures. Include travel funds for laboratory
personnel to attend CDC sponsored Level C training.
5. Ensure PHL staff obtain appropriate vaccinations
6.
[Text has been omitted for security
reasons as provided in R.C.W. 42.17.310(1)(ww)]
|
Tasks: What key tasks will be conducted in carrying out each
identified strategy?
|
1 Review/analyze current PHL capacity for testing Category A
agents
2a Prepare drafts of MOUs
2b Share drafts with partners
2c Obtain signatures on final draft 3a Monitor LRN website at
least weekly
3 Perform validations and run necessary QA/QC
4a Open Micro register and select names for interview. Offer
position
4b Train microbiologist to perform LRN validated procedures
5a Perform needs assessment for appropriate vaccinations
5b Obtain necessary vaccinations for staff
6
[Text has been omitted for security
reasons as provided in R.C.W. 42.17.310(1)(ww)]
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1 9/03
2a 11/03
2b 12/03
2c 2/04
3 Ongoing
4a 9/03
4b 10/03
5a-bOngoing
6 9/03
|
Responsible Parties: Identify the person(s) and/or entity assigned
to complete each task.
|
1 Micro OD
2a PHL Dir
2b-c PHL Dir
3 Micro OD
4a-b Micro OD
5a-b Safety Officer
6 Micro OD
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
|
1 Testing summary
2a-b Drafts
2c Final MOUs
3 Validated prtocols
4a Job offer
4b Training schedule
5a Vaccination assessment
5b Documentation
6 Documentation
|
Back to top
3. Ensure at least one public health laboratory in your
jurisdiction has the appropriate instrumentation and appropriately
trained staff to perform CDC-developed real-time polymerase chain
reaction (PCR) and time-resolved fluorescence (TRF) rapid assays.
Integrate new advanced rapid identification methods approved by
the LRN into the current laboratory-testing algorithm for human,
environmental, animal or food specimens. Contact CDC technical
support staff for further information on approved equipment as
necessary. (LINK WITH FOCUS AREA B)
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Identify and integrate advanced rapid identification
methods into PHL testing algorithm
2. Consult with CDC on necessary upgrades on new equipment
3. Inventory equipment available for bioterrorism testing and
purchase necessary approved equipment (include redundant
equipment for backup – APHL guidance, p41)
4. Purchase maintenance contracts for bioterrorism equipment
5. Request travel and fees for NLTN sponsored events (APHL
guidance, p41)
|
Tasks: What key tasks will be conducted in carrying out each
identified strategy?
|
1a Closely monitor LRN website for new protocols
1b Update testing algorithms following test validation
2a Monitor LRN website for recommended equipment upgrades
2b Establish plans for integration of new equipment
3a Update inventory of approved bioterrorism equipment
3b Plan for acquisition of necessary/redundant equipment
4a Inventory equipment with maintenance contracts and decide
on cost benefits of contracts
4b Purchase maintenance contracts
5 Plan travel for specific events of interest
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a-b Ongoing
2a-bOngoing
3a 10/03
3b 11/03
4a Done
4b 9/03
5 Ongoing
|
Responsible Parties: Identify the person(s) and/or entity assigned
to complete each task.
|
1a-b Micro OD
2a-b Micro OD
3a-b Micro OD
4a-b Micro OD
5 Training Manager
|
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
|
1a Schedule
1b Testing algorithm
2a Schedule
2b Plans
3a Inventory
3b Plan and purchase orders
4a Inventory
4b Contracts
5 Travel schedule |
Back to top
- CRITICAL BENCHMARK #14: Conduct at least one simulation
exercise per year, involving at least one threat agent in Category
A, that specifically tests laboratory readiness and capability to
perform from specimen threat assessment, intake prioritization,
testing, confirmation, and results reporting using the LRN
website. (MAY LINK WITH ALL FOCUS AREAS)
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Finalize plans for and participate in the upcoming full
scale bioterrorism exercise involving state, local, regional,
hospital and tribal entities (planned for Summer of 2004) (Link
with focus area G)
2. Participate in bioterrorism exercises with other
local/state/federal agencies (Link with focus area G)
3. Assess rule out capabilities of Level A laboratories with
challenge sets simulating category A agents
|
Tasks: What key tasks will be conducted in carrying out each
identified strategy?
|
1a Define PHL role in exercise
1b Attend planning meetings
2a Evaluate exercise outcomes and summarize
strengths/weaknesses
2b Define and implement necessary changes
3a Continue participation in CAP bioterrorism proficiency
program
3b Continue participation in CDC validation and proficiency
programs
|
Timeline: What are the critical milestones and completion dates for
each task?
| 1a 2/04 1b Ongoing
2a-b 8/04
3a-b Ongoing |
Responsible Parties: Identify the person(s) and/or entity assigned
to complete each task.
| 1a-b Div ERP 2a-b Div ERP
3a QA/QC Coordinator
3b QA/QC Coordinator |
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
|
1a Defined roles
1b Agendas
2a Evaluation
2b Revised procedures
3a Proficiency schedule
3b Proficiency results
|
Back to top
5. Ensure the availability of at least one operational
Biosafety Level 3 (BSL-3) facility in your jurisdiction. If not
immediately possible, BSL-3 practices, as outlined in the CDC-NIH
publication "Biosafety in Microbiological and Biomedical
Laboratories, 4th Edition" (BMBL), should be used (see
www.cdc.gov/od/ohs) or formal
arrangements (i.e., MOU) should be established with a neighboring
jurisdiction to provide this capacity
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Update MOUs with Public Health Seattle and King County (PHSKC),
Spokane Regional Health District (SRHD), the University of
Washington R.C.W. 42.17.310(1)(ww) and neighboring states, for
partnership in BSL-3 back-up capacity (immediate surge capacity)
|
Tasks: What key tasks will be conducted in carrying out each
identified strategy?
| 1a Prepare drafts of MOUs 1b Share drafts with partners
1c Obtain signatures on final draft |
Timeline: What are the critical milestones and completion dates for
each task?
Responsible Parties: Identify the person(s) and/or entity assigned
to complete each task.
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
| 1a Draft 1b E-mail
1c Final Draft |
Back to top
6. Ensure that laboratory registration, operations, safety, and
security are consistent, at a minimum with the requirements set
forth in Select Agent Regulation (42 CFR 73) "Possession, Use and
Transfer of Select Agents and Toxins; Interim Final Rule" and any
subsequent updates as detailed in www.cdc.gov/od/sap and
www.aphis.usda.gov/vs/ncie/bta.html. Pursuant to 18 USC section
175b, as added 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 as to 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. (LINK WITH FOCUS AREA D)
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Continue upgrade of PHL security to meet current CDC
standards for possession, use and transfer of select agents
(LINK TO FOCUS AREA D)
2. Ensure PHL staff are in compliance with the Patriot Act of
2001 regarding select agents
3. Continue with risk assessments of bioterrorism protocols
to ensure PHL staff are in a safe working environment
|
Tasks: What key tasks will be conducted in carrying out each
identified strategy?
|
1a Identify updates in CDC recommended standards for
laboratory security for select agents
1b Purchase equipment/supplies required to meet CDC
recommended standards
1c Identify security classes and send RO and ARO for training
2a Review elements of Patriot Act to ensure compliance
2b PHL staff involved in the handling of select agents will
undergo a security risk assessment
3a Complete risk assessment evaluations for all bioterrorism
protocols
3b Purchase equipment/supplies to ensure safe working
environment
3c Identify testing and safety needs of surge capacity
laboratories and include required upgrades in contracts/
cooperative agreements
|
Timeline: What are the critical milestones and completion dates for
each task?
|
1a 9/03
1b 1/04
1c Ongoing
2a 12/03
2b 10/03
3a 12/03
3b Ongoing
3c 12/03
|
Responsible Parties: Identify the person(s) and/or entity assigned
to complete each task.
|
1a Div ERP
1b Operations Manager
1c Training Manager
2a QA/QC Coordinator
2b Div ERP
3a Div ERP
3b Safety Officer
3c Bioterrorism Coordinator |
Evaluation Metric: How will the agency determine progress toward
successful completion of the overall recipient activity?
|
1a Updated standards
1b Purchase orders
1c Training documentation
2a Change documentation
2b Risk assessment documentation
3a Risk assessment documentation
3b Purchase orders
3c Consolidated contracts & MOUs |
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- Enhance electronic communications and LRN electronic
laboratory reporting, at the bench level, to enable integration
with CDC’s LRN capacity monitoring efforts, online results
reporting, sentinel surveillance,
proficiency testing, multi-center validation studies, and support
for future LRN site enhancements. Laboratories should participate
in reporting results of LRN proficiency testing electronically, as
they would in an actual event. Laboratories should have
appropriate computer equipment, firewall and high-speed Internet
connectivity to access the LRN’s protocols, reagents, and lab user
applications. (LINK WITH FOCUS AREA D, E AND CROSS CUTTING
ACTIVITY LABORATORY DATA STANDARD, Attachment X)
Strategies: What overarching approach(es) will be used to undertake
this activity?
|
1. Plan for PHL LIMS conformity with APHL Requirements
document
2. Continue development of PHL LIMS (Link with Focus Area E)
3. Include secure web interface with PHL LIMS
4. Participate with CDC to evaluate and determine the core
information technology capacity required to optimally respond to
bioterrorism events (APHL)
5. Provide "need to know" accessibility to LRN labs on
testing capabilities and capacities (APHL)
6. Maintain videoconferencing equipment (Link to focus area
G)
7. Purchase communication equipment (computers, etc.)
8. Assess the hardware, software, and high-speed Internet
connectivity capabilities of the LRN sites and develop a plan to
capitalize on these resources to develop laboratory-based
electronic exchange of data (Link to Focus Area E)
9. Participate with APHL/CDC to evaluate and determine the
core information technology capacity required of PHLs to
optimally respond to bioterrorism events (Link to Focus Area E)
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Tasks: What key tasks will be conducted in carrying out each
identified strategy?
| 1a Review APHL LIMS requirements 1b Incorporate
LIMS requirements in PHL planning for LIMS development
2 Plan meetings with APHL, CDC and PHL IT staff to develop
seamless LIMS
3 Coordinate d | |
