Agenda 03/26/2013 Item #16E33/26/2013 16.E.3.
EXECUTIVE SUMMARY
�1 Recommendation to approve a Memorandum of Agreement between the State of Florida Department of
Health and Emergency Medical Services as the CHEMPACK Cache Location for the purpose of
responding to acts of chemical emergencies posing a public health crisis.
OBJECTIVE. Provide secure storage of CHEMPACK Cache for the purpose of responding to acts of
chemical terrorism and other emergencies posing a public health crisis.
CONSIDERATIONS: The Board approved a Memorandum of Agreement between the State of Florida
Department of Health and Emergency Medical Services (DOH) as the CHEMPACK Cache Location
on October 10, 2006, Agenda Item 16F3. The State has requested a new agreement be executed.
The DOH will act on behalf of the State of Florida through its participation in the Strategic National
Stockpile Program (SNS Program), implemented by the Center for Disease Control (CDC). The CDC
will provide nerve agent antidotes and other necessary supporting equipment to care for individuals
exposed to nerve agents, including but not limited to auto - injectors, bulk symptomatic treatment
supplies, and self - monitoring storage containers. CHEMPACK is the sustainable repository of these
materials.
EMS, acting as the CHEMPACK Cache Location will authorize the breaking of the CHEMPACK
container seal and use of the packaged products when an accidental or intentional nerve agent release
has threatened the community. The Cache Location will also develop a plan for CHEMPACK
deployment, ensure adequate transportation of CHEMPACK material in an emergency and ensure the
security of CHEMPACK containers, along with other terms as outlined in the Memorandum of
Agreement.
The physical location of CHEMPACK cache will not be publicly disclosed to ensure the safety of such
materials.
FISCAL IMPACT: The CDC will provide the CHEMPACK through the SNS Program and will
maintain ownership of the materials at all times. The SNS Program will replace any CHEMPACK
material used in response to an actual nerve agent incident. There is an annual cost of approximately
$290 for a telephone line which is connected to the cache and monitored by the State. This charge is
paid by EMS Fund 490.
LEGAL CONSIDERATIONS: The County Attorney has reviewed this item which is legally sufficient
and requires a majority vote for Board approval. - JAK
GROWTH MANAGEMENT IMPACT: There is no Growth Management Impact resulting from this
action.
RECOMMENDATION. That the Board of County Commissioners:
1. Approve a Memorandum of Agreement between the State of Florida Department of Health and
Emergency Medical Services as the CHEMPACK Cache Location for the purpose of
responding to acts of chemical emergencies posing a public health crisis; and
2. Authorize the Chairwoman to execute said Agreement.
Prepared By: Artie Bay, Supervisor, Emergency Medical Services Admin.
Attachments: Memorandum of Agreement
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COLLIER COUNTY
Board of County Commissioners
Item Number: 16.16.E.16.E.3.
Item Summary: Recommendation to approve a Memorandum of Agreement between the
State of Florida Department of Health and Emergency Medical Services as the CHEMPACK
Cache Location for the purpose of responding to acts of chemical emergencies posing a public
health crisis.
Meeting Date: 3/26/2013
Prepared By
Name: BayArtie
Title: Supervisor - Accounting,EMS Operations
3/4/2013 1:38:28 PM
Approved By
Name: pochopinpat
Title: Administrative Assistant,Facilities Management
Date: 3/4/2013 3:22:21 PM
Name: KopkaWalter
Date: 3/8/2013 11:58:52 AM
Name: SummersDan
Title: Director - Bureau of Emergency Services,
Date: 3/11/2013 8:52:08 AM
Name: KlatzkowJeff
Title: County Attorney
Date: 3/13/2013 8:17:26 AM
Name: KlatzkowJeff
Title: County Attorney
Date: 3/13/2013 8:29:38 AM
Name: PryorCheryl
Title: Management/ Budget Analyst, Senior,Office of Manag
/0-111 Date: 3/15/2013 12:58:57 PM
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MEMORANDUM OF AGREEMENT
Between
THE STATE OF FLORIDA DEPARTMENT OF HEALTH
And
Collier County EMS
Purpose
This Memorandum of Agreement (MOA) is entered into between the State of Florida
Department of Health, (DOH or Department), and COLLIER COUNTY EMS
(CHEMPACK Cache Location), for the purpose of effectively responding to acts of
chemical terrorism and other chemical emergencies posing a public health crisis.
The Centers for Disease Control and Prevention (CDC) agrees to pre - position
sustainable repositories of nerve agent antidotes (CHEMPACKs) in locations in
Florida. This MOA establishes the terms, conditions, and responsibilities between
the parties for deployment, management, and maintenance of this federally owned
asset. This MOA is subject to the provisions of all applicable Federal and State laws,
regulations, policies and standards.
Parties
The Parties to this MOA are the Department and the CHEMPACK Cache Location.
The Department will carry out the responsibilities in this MOA on behalf of the State
of Florida through its participation in the Strategic National Stockpile Program (SNS
Program), implemented by the CDC.
The Coordinator /State Project Manager for DOH:
Linda Bailey
Florida Department of Health /Bureau of Preparedness & Response
2702 Directors Row
Orlando, FL 32809
407 -414 -9130
The Point of Contact (POC) for the CHEMPACK Cache Location:
Name
Facility Name
Address
City, State, Zip Code
Phone Number
Definitions
Dan Summers
Emergency Medical Services
8075 Lely Cultural Pkwy
Naples, FL 34113
239 - 252 -3740
For purposes of this MOA, the terms shall be defined as follows:
CHEMPACK -The sustainable repository of nerve agent antidotes and other
necessary and supporting equipment to care for individuals exposed to nerve agents,
auto - injectors, bulk symptomatic treatment supplies, and self - monitoring storage
containers. CHEMPACK is a component of the SNS Program. This CHEMPACK
Project provides two types of containers. The EMS container is designed for use by
emergency responders; asset(s) packaged primarily in auto - injectors. The Hospital
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container is designed for hospital dispensing; asset(s) packaged primarily in multi -
dose vials, for precision dosing and long -term care.
Shelf Life Extension Program (SLEP) -The Food and Drug Administration's (FDA)
SLEP is designed to maintain the readiness and effectiveness of pharmaceuticals
over extended periods of time. The SLEP defers costs by extending the expiration
date of stored pharmaceuticals rather than replacing stocks that have reached a set
expiration date. Through centrally located automated monitoring devices, the SNS
Program staff is able to ensure that conditions of CHEMPACK asset(s) comply with
SLEP guidelines, thus enabling CHEMPACK to provide the State a long -term
capability.
Strategic National Stockpile Program (SNS Program) - Implemented by the CDC.
SNS Program Personnel, SNS Program POC, SNS Program CHEMPACK
Logistics Team, SNS Program CHEMPACK Fielding Team - individuals or teams
working under the direction of the SNS Program and the CDC.
State Point of Contact (State POC) and Alternate State Point of Contact
(Alternate State POC)-The Florida DOH Statewide point of contact and the Florida
DOH Alternate Statewide point of contact.
Cache Location POC (Cache Location POC) and Cache Location Alternate POC
(Alternate Cache Location POC) -The designated point of contacts specific to the
Cache Location.
IV. Department Responsibilities
The Department agrees to the following:
1. Provide authority or delegate authority for breaking the CHEMPACK container
(Appendix 1, page 9, attached to this MOU) seal and use of the packaged
products.
2. Designate a State POC and an Alternate State POC for the CHEMPACK Project.
Provide corresponding contact information and notification of any changes in
contacts.
3. Develop a CHEMPACK Operational Plan for deployment, surveillance and
maintenance operations as an addendum to Florida Comprehensive Emergency
Management Plan (FL CEMP) and the DOH Emergency Operations Plan (EOP).
4. Provide addresses of all cache storage location sites and ensure pre- coordinated
access for SNS Program Personnel.
5. The cache storage locations meet size, environmental, and security conditions
for storage of pharmaceuticals based upon the DEA, FDA, and SNS Program
Storage Criterion.
6. The proper disposal in accordance with applicable federal, state, and local
regulations of expired CHEMPACK medical asset(s) and copies of the
destruction documentation to the SNS Program.
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7. Conduct joint inventories with the Chempack Fielding Team upon initial
placement and approximately every twelve to twenty four (12 -24) months
thereafter.
B. Quality control checks are conducted for environmental limits at cache locations
and ensure the submission of a quarterly CHEMPACK Project Quality Assurance
Survey.
9. Adequate transportation of CHEMPACK asset(s) in an emergency, to include
coordinating with state, local officials and emergency planning members for use
of vehicles, freeway routes, and airfields.
10. Storage facilities have the capability to rapidly move CHEMPACK asset(s) as
required. This may include hydraulic lifts, forklifts, loading docks, or ramps.
11. Provide a list of personnel with access to the CHEMPACK containers at each
cache location to the SNS Program POC at the time of fielding and update as
changes occur.
12. Cache storage locations are correct non - compliant environmental and security
conditions identified by SNS Program POC in a timely manner.
13. Coordinate with SNS Program Personnel to ensure security and environmental
conditions are met for CHEMPACK asset(s) during any non - emergency
movement (i.e., special events).
14. Notify the SNS Program within twenty four (24) hours of an emergency
deployment. The deployment report should identify the amount of CHEMPACK
expended and the amount of asset(s) returned to the container.
15. In the event of a non - emergency use or compromise of CHEMPACK asset(s);
the State will report the loss to the SNS Program as soon as possible following
discovery. Within forty eight (48) hours of the discovery of the loss, the State
must submit a report documenting the circumstances resulting in the loss and
providing an inventory of asset(s) lost or destroyed.
V. CHEMPACK Cache Location Responsibilities
The CHEMPACK Cache Location agrees to the following:
1. Authorize breaking the CHEMPACK container seal and use of the packaged
products when an accidental or intentional nerve agent release has threatened
the medical security of the community; has multiple lives at risk; is beyond local
emergency response capabilities; is beyond local pharmaceuticals' supplies; and
the asset(s) is /are medically necessary to save lives.
2. Designate a Cache Location POC and a Cache Location Alternate POC position
for CHEMPACK and provide contact numbers for normal business hours and
after hours to the Department. Notify the Department at (850) 245 -4444,
extension 2089 or 245 -4444, extension 3705 and /or via email to the Department
Contract Manager of any changes in contact personnel within one business day
of assignment of a new Cache Location POC.
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3. Ensure each cache site is assigned a separate DEA registration license number,
not a practitioner license. Identify a pharmaceutical or medical professional with
a Drug Enforcement Agency (DEA) registration for the Cache Storage Location
that will sign for and accept custody of the Schedule IV controlled substances
and other pharmaceuticals in CHEMPACK containers. That person will be
responsible for the storage and safeguarding of the DEA compliant container in
the facility and ensure compliance with applicable local, state and federal
regulatory guidelines. Provide the custodian's name, license number, and
contact information to DOH at the time of scheduled delivery to a cache location.
Notify the Department of any changes in contact personnel within one business
day of assignment of a replacement with DEA registration.
4. Develop a plan for CHEMPACK deployment, surveillance and maintenance
operations. The plan may be an annex to the facility all- hazards plan. The plan
should address: asset placement; distribution; coverage areas; procedures for
control, authorization and use of CHEMPACK assets; access coordination
procedures to include how asset(s) could be shared with health care facilities
within the coverage area; and submission of reports that may be required.
Provide copies of this plan to the DOH State POC, the Regional Emergency
Advisors (RERAs), and the county Emergency Managers within 4 months of
receiving CHEMPACK asset(s).
6. Provide adequate transportation of CHEMPACK asset(s) in an emergency, to
include coordinating with state, local officials and emergency planning members
for use of vehicles, freeway routes, and airfields.
6. Storage facilities have the capability to rapidly move CHEMPACK asset(s) as
required. This may include, but is not limited to, hydraulic lifts, forklifts, loading
docks, or ramps.
7. The cache storage locations are of a suitable size; designed to provide adequate
lighting, ventilation, temperature control that results in a mean kinetic
temperature calculated to be no more that 77 °F, provide sanitation, space and
security conditions for storage of pharmaceuticals; and conform to the
CHEMPACK storage standards listed in the CHEMPACK Quarterly Qualify
Assurance Survey.
8. Conduct proper disposal in accordance with applicable federal, state, and local
regulations of expired CHEMPACK medical asset(s) and provide copies of the
destruction documentation to the SNS Program. Coordinate with State POC and
SNS Program Personnel prior to disposal. Such disposal will not be at the Cache
Site's expense.
9. Authorize access for joint inventories with the CHEMPACK Fielding Team upon
initial placement and approximately every 12 to 24 months thereafter. Authorize
access for monitoring or monthly security checks to visually inspect SNS
Program seals on the CHEMPACK containers (in accordance with applicable
federal and state regulations for the person signing for custody as duly registered
with the DEA).
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10. Authorize access for quality control checks at each CHEMPACK Cache Location
�-� to ensure the facility's climate is within acceptable environmental limits and
submit a quarterly CHEMPACK Quality Assurance Survey to document storage
conditions at the cache location to SNS Program.
11. Allow CHEMPACK asset(s) to be shared with other requesting facilities
according to the criteria set forth in this document. Unless arranged otherwise,
the cost for transportation shall be reimbursed as agreed between the parties in a
"Letter of Agreement" or "Mutual Aid Agreement."
12. Provide proper security of CHEMPACK containers. Establish a list of personnel
with access to the CHEMPACK containers at the CHEMPACK Cache Location,
disclose the list with the State POC, and update the list as necessary.
13. Provide cache storage locations correct non - complying environmental and
security conditions identified by SNS Program POC in a timely manner (usually
within one hour). When conditions cannot be corrected within 12 hours, the SNS
Program CHEMPACK Logistics Team will coordinate with the State POC to
move CHEMPACK container(s) to an acceptable location to safeguard the quality
or security of the asset(s).
14. Notify State POC and the SNS Program CHEMPACK Logistics Team within two
hours if a CHEMPACK cache storage location loses climate control. Any reports
of material stored outside of the accepted storage range will be handled on a
case -by -case basis. Outcomes could range from having the asset(s) remain in
the SLEP to removing the material from the SLEP program and the State
forfeiting the long -term sustainability of the resource.
15. In the event of a non- emergency use, or compromise of CHEMPACK asset(s);
the facility will report the loss to the State POC as soon as possible following
discovery. The facility must submit a report documenting the circumstances
resulting in the loss and providing an inventory of CHEMPACK asset(s) lost or
destroyed within 24 hours of discovery or next business day.
16. In the event the Chempack must be deployed for emergency use, notify the
Coordinator /State POC immediately by telephone and provide a written report
within a reasonable timeframe for DOH to meet Chempack obligations.
17. Chempack assets will be provided to patients free of charge.
VI. Financial Considerations
Except where otherwise detailed in this MOA, each party is responsible for its own
costs. Any assistance provided by the State of Florida under this MOA and any
assistance provided by the CDC is subject to the availability of appropriations. The
SNS Program is not currently funded to replace any CHEMPACK asset(s) used in
response to an actual nerve agent incident. If such an event occurs, however, the
SNS Program will cooperate with the State in attempting to secure federal funding to
replenish /replace expended CHEMPACK asset(s). Replacement of CHEMPACK
asset(s) due to circumstances beyond the control of the parties, such as accident
and natural disasters, will be negotiated between the State and the SNS program on
a case -by -case basis.
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VII. Ownership
The CDC shall at all times retain ownership of CHEMPACK asset(s) in storage.
Subject to the terms of an MOA between the CDC and the State of Florida, the CDC
has granted the State, and CHEMPACK Cache Storage Locations approved by
CDC, permission to use CHEMPACK asset(s) in the event of an accidental or
intentional nerve agent release that threatens the medical security of the community,
puts multiple lives at risk, and is beyond local emergency response capabilities.
Vlll. Storage
State and local agencies and CHEMPACK Cache Locations may only store the
asset(s) provided as part of the CHEMPACK Project in the SNS- provided containers.
State -owned and SNS Program -owned nerve agent antidotes may not be co- mingled
in storage containers since co-mingled storage will compromise the SNS Program's
ability to maintain the CHEMPACK asset(s) under the SLEP.
IX. Movement for Special Events
The CDC has authorized the State to move CHEMPACK for State - designated
special events (e. g., National Special Security Events, Super Bowl, World Series,
major political conventions, state fair, a major concert, and key summits) on a
temporary basis. The temporary movement of CHEMPACK asset(s) is subject to the
following conditions: (1) the State POC or Alternate State POC must notify the SNS
Program by telephone or in writing at least 48 hours prior to the preemptive
movement of CHEMPACK containers; (2) state Chempack staff will provide all
information outlined on the Request Form for Temporary Container Movement in ^
writing to the Regional CDC Contact (3) the State shall ensure that environmental
and security requirements outlined in the MOA with CDC are maintained throughout
transport and preemptive deployment; (4) only locations hosting more than one
container shall participate; and (5) any movement of CHEMPACK asset(s) not
specifically directed by the SNS Program shall be funded by the State. If the
CHEMPACK Cache Location wishes to move CHEMPACK asset(s), it must request
permission from the State POC or Alternate State POC who will, in turn, notify the
SNS Program in the manner described above.
X. Compliance with U.S. Drug Enforcement Agency Requirements
The State agrees to comply with all applicable federal, state, and local requirements
regarding storage, use, and handling of controlled substances. A non - exclusive list
of federal requirements regarding the storage, use, and handling of these
substances may be found at Title 21 Code of Federal Regulations Part 1301. In
addition, the CHEMPACK Cache Location agrees to designate a pharmaceutical or
medical professional with a DEA registration who will sign for and accept custody for
controlled substances and other pharmaceuticals in CHEMPACK containers at each
cache storage location. The CHEMPACK Cache Location designee will be
responsible for the storage and safeguarding of controlled substances within the
CHEMPACK container and ensure compliance with federal, state, and local
requirements. The State POC must provide the custodian's name, license number
and contact information two (2) weeks prior to the scheduled delivery of a cache
location.
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XI. Public Disclosure
Under 42 USC § 247d -6b, no federal agency shall disclose under 5 USC § 552,
United States Code, any information identifying the location at which SNS Program
asset(s) are stored. To the extent permitted by law, the parties agree that neither will
disclose the nature of this effort and the terms of this agreement to any person or
entity, except as may be necessary to fulfill its mission and statutory and regulatory
responsibilities. The parties agree to notify one another before releasing asset(s) or
information relating to CHEMPACK or this MOA pursuant to federal or state freedom
of information act statutes or similar provisions in law. Pursuant to sections 381.95
and 395.1056 Florida Statutes, this document is confidential and exempt from
disclosure as a public record under Chapter 119 F.S.
XII. Liability
Each party of this MOA shall be responsible for its own acts and omissions and
those of its officers, employees and agents. No party to this agreement shall be
responsible for the acts or omissions of entities not a party to this agreement.
Neither party to this MOA agrees to release, hold harmless, or indemnify the other
party from liability that may arise or relate to this MOA.
XIII. Effect on Procedures and Laws
All assistance provided under this MOA must comply with applicable laws,
regulations, and agency policies.
XIV. No Private Right Created
This document is an internal agreement between the Department and the entity with
custody or control of a CHEMPACK Cache Location and does not create or confer
any right or benefit on any other person or party, private or public. Nothing in this
agreement is intended to restrict the authority of either signatory to act as provided
by law or regulation, or to restrict any agency from enforcing any laws within its
authority or jurisdiction.
XV. Settlement of Disputes
The parties agree to good faith consultation with one another to resolve
disagreements that may arise under or relating to this MOA before referring the
matter to any other person or entity for settlement.
XVI. Capacity to Enter into Agreement
The persons executing this MOA on behalf of their respective entities hereby
represent and warrant that they have the right, power, legal capacity, and
appropriate authority to enter into this agreement on behalf of the entity for which
they sign.
XVII. Effective Date, Modification, and Termination
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This MOU shall become effective upon the signature of both parties and shall remain
in effect until otherwise agreed to by the parties. The terms of this agreement may
be modified in writing upon the consent and signature agreement of both parties.
This agreement may be terminated by either party at any time; however, the
terminating party shall provide written notice to the other party at least six months in
advance of the effective date of termination unless there is a critical violation of the
terms set forth in this MOA. In the event of termination, all SNS Program equipment,
related records, and /or other asset(s) generated by or for the CHEMPACK Project in
furtherance of this agreement are property of the SNS Program and shall be returned
to the SNS Program within six months of the termination date.
IN WITNESS THEREOF, the parties hereto have caused this nine (9) page MOA to
be executed by their officials there unto duly authorized.
CHEMPACK CACHE LOCATION
SIGNED BY:
STATE OF FLORIDA
DEPARTMENT OF HEALTH
SIGNED BY:
NAME: GEORGIA A. HILLER, ESQ. NAME: Victor Johnson
TITLE: CHAIRWOMAN TITLE: Interim Director. Division of Emergency
Preparedness and Community Support
DATE:
FEDERAL ID NUMBER:
and
DATE:
This Page Left Intentionally Blank
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/1-1 Appendix I — CHEMPACK Container Contents, Cubes, and Weights
EMS CHEMPACK Container for 454
Product UOM
QTY
Case
Lbs.
Mark 1 auto - injector with -240 kits
CS
5
39.5
Atropine Sulfate 0.4m /ml 20ml -100 vials
CS
1
12
Pralidoxime 1 gm in' 20ml -276 vials
CS
1
11.5
Atro en .5M . -144 injectors
CS
1
16.8
Atro en 1 Mg.-144 injectors-
CS
1
16.8
Diazepam 5m /ml auto - injector -150 injectors
CS
2
20
Diazepam 5m /ml vial, 10ml -50 vials
CS
1
3.6
Sterile water for injection (SWFI) 20ml -100
vials
Hospital
Product
CS
000
UOM
2
QTY
7.2
Case
Lbs.
Mark 1 auto - injector -240 kits
CS
2
39.5
Atropine Sulfate 0.4m ml 20ml -100 vials
CS
9
12
Pralidoxime 1 m in' 20ml -276 vials
CS
10
11.5
Atro en .5M . -144 injectors
CS
1
16.8
Atro en 1 Mg.-144 injectors
CS
1
16.8
Diazepam 5m ml auto - injector -150 injectors
CS
1
20
Diazepam 5m /ml vial, 10ml -50 vials
CS
13
3.6
Sterile water for injection (SWFI) 20ml -100
vials
CS 1
28
7.2
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