05-995� Council File # ��_ � N
Green Sheet #
Presented By:
RESOLUTION
PAUL, MINNESOTA
3028310
�7
Referred To: Committee: Date
� W HEREAS, the President of the United States, the Secretary of the U. S. Department of Homeland Security,
z the Centers for Disease Control, and the Minnesota Department of Health Department recognize that various
a chemicals which attack the human central nervous system may be accidentally or intentionally released on the
a population of the United States, and
6 WHEREAS, the rapid administration of antidote pharmaceuticais is a proven means of combating nerve agent
� exposure, thus saving lives and reducing injuries, and
9 WHEREAS, maintaining pre-positioned caches of the antidote pharmaceuticals in large metropolitan areas
�o such as Saint Paul through a system called CHEMPACK provides an excellent opportunity to reduce the time
�� from exposure-to antidote administration, and reduces the likely impact of a nerve agent incident, and
iz
is W HEREAS, the Emergency Medical Services and Emergency Management functions of the City of Saint
ia Paul, Department of Fire and Safety Services, are prepared to administer the antidote pharmaceuticals when
is necessary, and will be responsible for the security, maintenance, and use of the nerve agent antidotes
�s contained in CHEMPACK,
n
ia NOW, THEREFORE IT BE RESOLVED, that the Saint Paul City Council does hereby authorize appropriate
is City officials to enter into and execute the attached Joint Powers Agreement with the State of Minnesota,
zo Department of Health, for the establishment, maintenance, and use of the CHEMPACK nerve agent antidote
zi repository.
zz
23
24
Requested by Department of:
Adopted by Council: Date �G��� �� , aOO�
Adoption Certified by Councii Secretary:
�
Date /�- 3�'
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F' & Safe Services
By:
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Approval Recommended by Director of Financial Services:
By:
Form
By:
by City
for
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� Green Sheet Green Sheet
OS °F�S
Green Sheet Green Sheet Green Sheet Green Sheet �
DepartmenUOffice/councii: Date Initiated:
FR — Fire o��_os Green Sheet NO: 3028310
Conpct Person 8 Phone: Deoartrnent Sent To Person / I T nitial/ , �Da�te
Tim BuNer � 0 ire �
22&62�� A55ign 1 ire De artmentDireMOr �
Must Be on Councii /�qenda by (Date): Number 2 � A � o �
For
RoUting 3 a or's O�ce Ma or/A istant
Ofd2f 4 uncil
5 i Clerk Ci Clerk
Total # of Signature Pages _(Clip All Locations for Signature)
Action Requested: '
Approval of the attached Council Resolution authorizing the appropriate City officials to sign and execute the attached Joint Powers
Agreement with the State of Minnesota, Deparhnent of Health to host a pharmaceurical cache called CHEMPACK.
Recommendations: Approve (A) or Reject (R): Personal Service Contracts Must Mswer the Following Questions:
Planning Commission 1. Has this person/firm ever worked under a contrect for this department?
CIB Committee Yes No
Civil Service Commission 2. Has this person/firtn ever been a city employee?
Yes No
3. Does this person/firm possess a skill not normally possessed by any
current ciTy employee?
Yes No
Explain all yes answers on separate sheet and attach to green sheet
Initiating Problem, Issues, Opportunity (Who, What, When, Where, Why):
In order to *+�inimi�e the harmfiil effects of a nerve agent chemical weapons attack or an accidental release of organophosphate
pesticide/insecticide chemicals, the Centers for Disease Control and the Minnesota Departmem of Health will supply a sustainable
repository of antidote pLanvaceuticals in Saint Paul. Execution of the Joint Powers Agreement would enable local officials to host this
repository.
AdvantageslfApproved:
The City of Saint Paul will be able to save lives, reduce injuries, and shorten the recovery period for many citizens and responders who
aze exposed to chemicals which attack the central nervous system
DisadvantageslfApproved:
None.
Disadvantages If Not Approved:
�� Immediate administrarion of antidote phazmaceuricals will not be possible, resulting in increased number of injured or dead.
Total Amount of CostlRevenue Qudgeted:- -- — � - - — � �� � � � �
Transaction: .
Funding Source: Activity Number:
�� °.'�'`��'�f.s��,�.,E„ �'.nnb,.r OCT 12 2005
� Financiallnformation: '
(Explain) Q'! � ry
U��I 1 J Gi36�J �d'� T/°9 C!��@Y�
o�- q�s
CFMS Coniract No.
STATE OF MINNESOTA
JOINT POWERS AGREEMENT
This agreement is between the State of Minnesota, acting through its commissioner of the Minnesota Department of Health
and the Ciry of Saint Paul, Department ofFire and Safety, 100 E. 11�' S�eet, St. Paul, Minnesota, 55101.
Recitals
1. Under Minn. Stat. § 471.59, subd. 10, the State is empowered to engage such assistance as deemed necessary. The
State has entered into an agreement (the "Memorandum of Understanding" or "MOU" — Attachment A) with the
Centers for Disease Control and Prevention (CDC) under which the CDC will place sustainable repositories of nerve
agent anfidotes ("CHEMPACK") in locations in Minnesota. The State is in need of suitable storage facilifies Por
C:HEMPACK materials received from the CDC. The State is also in need of assistance with the appropriate
maintenance of these storage facilities so that the effecriveness and security of the CHEMPACK materials will not be
compromised. .
Agreement �
Term of Agreement
1.1 Effective date: October 21, 2005, or the date the State obtains all required signatures under Minnesota Statutes
Section 16C.05, subdivision 2, whichever is later.
1.2 Expiration date: October 20, 2010, or until all obligarions have been satisfactorily fulfilled, whichever occurs
first.
2 Agreement between the Parties
2.1 Local Governmental Unit's responsibility;
a) Store CHEMPACK materials at one or more cache sites located in a building or buildings owned by the I,ocal
govermnental unit at 273 White Bear Avenue, St. Paul, Minnesota, 55101;
b) Store CHEMPACK materials only in the containers provided by the CDC for that purpose;
c) Nofify the State's Authorized Representafive of the specific cache site location for each cache site;
d) Break or authorize the brealdng of the CHEMPACK container seal and use the packaged products only when a
designated competent authority, "competent authority" is defined as a"credentialed medical professional" ,
deternune that an accidental or intentional nerve agent release has threatened the medical security of the
community; has put mulriple lives at a risk; is beyond local emergency response capabiliries; and the materials
aze medically necessary to save lives;
e) Immediately nofify the State Duty Officer at 651-649-5451 or 1-800-422-0798 if a decision is made to break
open the CHEMPACK container located at the cache site;
� Modify Local govemmental unit's existing emergency response operations plans to incorporate CHEMPACK
materials into the Local governmental uniYs procedures;
g) Designate a single person to be the cache site point of contact (POC) for CHEMPAC'I� with three deep
redundancies.
h) Provide to the State's Authorized Representarive and the CDC's designated representative the POC's contact
numbers during normal business hours and after hours (office phone, cell phone, pager, email and fax);
i) DesiBnate two alternate POC's (AP�C) to backup the POC, and provide to the State's Authorized
Representafive the conesponding contact information for the APOC;
j) Notify the State's Authorized Representarive of any changes in the POC or APOC within one business day of
assignment of a new POC or APOC.
k) For each cache site, complete an Cache Facility Survey in the form of Appendix 2, attached hereto and made a
part of this contract, and submit it to the State's Authorized Representafive for review;
7oint Powers Agreement (Rev. 6/03)
D5-99�
CFMS ContractNo.
1) Participate in cache site surveys along with representarives of the CDC and State, to ensure that each cache site
complies with standards of the Minnesota Board of Pharmacy and the United States Drug Enforcement Agency
(DEA);
m) Upon delivery of CI�MPACK containers to I,ocal govemmental uniYs address, assist CDC with labor and
any necessary material handling equipment to push the wheeled CHEMPACK container(s) to their storage
area(s)•
n) Sign for receipt of on-tiand quantifies once agreed to, and assume custody of on-hand quantiries;
o) Ensure pre-coordinated access for CDC and State personnel to cache sites as needed to monitor CFIEMPACK
materials;
p) Identify a pharrnaceutical or medical professional with a DEA registration for cache storage location who will
sign for and accept custody of the Scheduled N controlled substances and other phazmaceuticals in
CHEMPACK containers, who will accept responsibility for the storage and safeguarding of the DEA
compliant container in the facility, and who will ensure compliance with applicable local, state and federal
regulatory guidelines;
c� Ensure that cache sites maintain adequate lighting, ventilation, temperature conirol, sanitation, huxnidity, and
space and security conditions for storage of pharmaceuricals, accordance with the standards set forth in
Appendix I which is attached and made part of this agreement;
r) Conduct joint inventories with CDC and State staff upon initial placement of CHEMPACK at the cache sites
and approximately every 18 months thereaffer;
s) Conduct monthly securiry checks to visually inspect seals on the CHEMPACK containers;
t) Conduct quality control checks at each cache site to ensure the facility's climate is within acceptable
environmental limits and submit to the State's Authori2ed Representative and the CDC's representafive a
monthly CHEMPACK Project quality control (QC) checldist to document starage conditions at the cache site;
u) Ensure that the Local goveminental unit is properly prepared to perform the dufies assigned to the Local
govemmental unit under the regional CHEMPACK plan in the Local governmental uniYs region in the event
of a nerve agent release. These duties may include, but are not limited to, rapid movement of CHEMPACK
materials, such as by using hydraulic lifts, forklifts, loading docks, or ramps;
v) Ensure proper security of CHEMPACK containers;
w) Upon delivery of CFIEMPACK containers to Local governmental uniYs address, provide to the State's
Authorized Representative and the CDC's designated representative a list of Local governmental uniYs
personnel with access to the CHEMPACK containers at each cache site, and update the list ifthese personnel
ohange;
x) Respond 24/7 and remedy cache site alann activations due to unauthorized access, temperature fluctuation, or
humidity fluctuation; report remedy to the State's Authorized Representarive within 24 hours;
y) In the event of any unauthorized access to the integrity of CfIEMPACK containers at a cache site, immediately
report this to the State Duty Officer by calling 651-649-5451 or 1-800-422-0798, and participate in resulting
joint re-inspection and re-inventory with representafives of the State and the CDC;
z) Correct non-complying environmental and security condirions idenrified by State staff in a timely mamier
(usually within one hour); cooperate with the State to move CHEMPACK container(s) to an acceptable
locafion to safeguard the quality or security of the materials, if the State determines that such movement is
appropriate;
aa) Notify the State Duty O�cer by calling 651-649-5451 or 1-800-422-0798 within two hours if a CHEMPACK
cache site loses climate control;
bb) Ensure ongoing Education and training of Local governmental uniYs key staff at the building(s) where the
cache sites are located;
cc) Participate in exercises focused on CHEMPACK, as requested by the State;
dd) Develop and keep current, in 000rdinarion with the State, procedures for accessing the CHEMPACK materials
stored at the cache sites; and
ee) With respect to CHEMPACK, comply with all applicable federal, state, and local requirements regarding
storage, use, and handiing of controlled substances. A non-exclusive list of federal requirements regazding the
storage, use, and handling of these substances may be found at Title 21 Code of Federal Regulations Part 1301.
7oint Powexs Agreement (Rev. 6/03)
D�-99s'
CF'MS ContractNo.
2.2 State's Duties
(a) Request that the CDC deliver CHEMPACK materials to the address(es) referred to in clause 3(a) of this coniract.
The CDC will provide CHEMPACK in two types of containers: 1) The Emergency Medical Service (EMS)
container that is designed for use by emergency responders, in which the CHEMPACK materiel is packaged
primarily in auto-injectors; and 2) "P�ie Hospital container that is designed for hospital dispensing, in which the
CI�MPACK materiel is packaged primaz�ily in mulri�ose vials, for precision dosing and.long-term caze;
(b) Conduct cache site surveys, along with representatives of the CDC and the Local govemmental unit, to ensure that
each cache site complies with Miimesota Board of Pharmacy and DEA standazds;
(c) Conduct joint inventories of each cache site, with the CDC and the POC;
(d) Develop and maintain access procedures for access to each cache site, in coordination with the CDC and the POC;
(e) In the event the State receives a report of any unauthorized access to the integrity of CHEMPACK containers at a
cache site, immediately report this unauthorized access to the CDC, and participate in joint re-inspection and re-
inventory of the cache site;
(fl Develop educarion, training and exercises in connecfion with CHEMPACK;
(g) Develop the treatment protocols to be used in Mimiesota in the event of a nerve agent exposure;
(h) Provide technical assistance to the Local govemmental unit, at the Local govemmental uniYs request; and
(i) Attempt to secure federal funding to replenish/replace expended CHEMPACK materials, if any of the
CHEMPACK materials from the cache sites aze used in response to an actual nerve agent incident. The Local
governmental unit understands that there is not currently any funding to replace expended CHEMPACK materials.
The state will coordinate with CDC in the disposal of expired materials.
3 Payment
The parties shall each bear their own costs associated with this agreement.
4 Authorized Representatives
The State's Authorized Representarive is Ginny Bazesch RN, MPH, State Coardinator, Strategic National Stockpile
Program, Mimiesota Department of Health, Office of Emergency Preparedness, 85 East 7th Place (P.O. Box 64882),
St. Paul, MN 55167-0882, phone: (651) 284-0603, fas: (651) 215-8895, email: �v.baresch@healthstate.mn.us, or
his/her successor.
The Local Goveminental Unit's Authorized Representative is Chief Tim Butler, St. Paul Fire, CiTy of St. Paul,
Minnesota, 55101, phone: (651) 228-6215, email: tim.butlerna ci.stpaul.mn.us or his successor.
Assignment, Amendments, Waiver, and Contract Complete
5.1 Assignment The Local Govemmental Unit may neither assign nor transfer any rights or obligations under this
ageement without the prior consent of the State and a fully executed Assignment Agreement, executed and
approved by the same parties who executed and approved this agreement, or their successors in office.
5.2 Amendmeats. Any amendment to this ageement must be in wriring and will not be effective until it has been
executed and approved by the same parties who executed and approved the original agreement, or their successors
in office.
5.3 Waiver. If the State fails to enforce any provision of this agreement, that failure does not waive the provision or its
nght to enforce it.
5.4 Contract Comple[e
Governmental Unit.
bind either parry.
This agreement contains all negotiations and agreements between the State and the Local
No other understanding regazding this agreement, whether written or oral, may be used to
6 Liability
Each party will be responsible for its own acts and behaviar and the results thereof. If any claim or cause of action is
asserted against a party in connection with the performance of this contract, that party shall promptly notify the other
party of the claim or cause of action. The parties shall cooperate with each other in the defense of claims and causes of
acrion arising out of the perfonnance of tlus contract.
Joint Powers Agreement (Rev. 6/03)
d5�-99�
CFMS Contract No.
7 State Andits
Under Minn. Stat. § 16C.05, subd. 5, the Local Govemmental UniYs books, records, documents, and accounting
procedures and practices relevant to this agreement ue subj ect to examination by the State and{or the State Auditor or
Legislative Auditor, as appropriate, for a minimum of six yeazs from the end of this agreement.
Government Data Praetices �
The I,ocal Govemmental Unit and State must comply with the Minnesota Goveinment Data Practices Act, Mimi. Stat.
Ch. 13, as it applies to all data provided by the State under this agreement, and as it applies to all data created,
collected, received, stored, used, maintained, or disseminated by the Local Govemmental Unit under this agreement.
The civil remedies of Minn. Stat. § 13.08 apply to the release of the data referred to in this clause by either the Local
Govemmentai Unit or the State.
If the Local Governmental Unit receives a request to release the data referred to in this Clause, the Local Govemmental
Unit must imFnediately notify the State. The State will give the Local Govemmental Unit instructions concerning the
release of the data to the requesting party before the data is released.
9 Venue
Venue for all legal proceedings out of this agreement, or its breach, must be in the appropriate state or federal court
with competent jurisdicrion in Ramsey County, Minnesota.
10 Termination
101 Terminarion. The State or the Local Governmental Unit may terminate this agreement at any time, with or
without cause, upon 30 days' written norice to the other party.
1. LOCAL GOVERNMENTAL UNIT Z,
By: _
(with
Title:
Date:
itle: � �
Date: % � a�
4. COMMISSIONEROFADMINI5TRATION
delegated to Materiats Mar�agement Division
�
Title:
Date:
Distnbution: � �
Agency
Local Govemmentai Unit
Sfate's Authorized Represeniative PhoW Copy
Joint Powers Ageement (Rev. 6/03)
p 5�-995
Appendix I— Cache Site Responsibility for Cache Storege Standards for Schedule IV
Controlled Substances and Pharmaceuticals are based upon the
following DEAand FDACriterion
1. provide a locked room or cage. The CHEMPACK container is constructed of LexanOO mesh and is
approved by the Drug Enforcement Agency (i.e., double locked standard, 24/7 security monitoring,
and controlled designated entry) for storage of Class IV controlled substances. For this reason,
there is no requiremenf for floor to ceiling constructibn. The purpose of the enclosed room or cage
is to control access and ensure compliance with applicable federal, state and Iocal pharmaceutical
regulations.
2. install an intrusion detection device, directed towards the CHEMPACK containers, to alert cache
location security or pharmacy personnel of possible intrusion into the storage area. The sensor
must be physically monitored on a 24-hour basis by security or pharmacy personnel. Cache
location security managers will test the interior devices according to manufacturer specifcations
to ensure proper operation.
3. ensure each container is locked with a padlock and access to the key is limited; key control shall
be the responsibility of the DEA registrant and/or the cache location pharmacy director.
4. ensure a minimum clearance of 72" aisles and 34" doonvays to maneuver containers in and out of
the storage location.
5. provide a minimum of 40 sq, ft. of floor space per container at each cache location.
6. ensure CHEMPACK containers are stored in a climate-controlled environment with room
temperature maintained between 59 to 86 degrees Fahrenheit (15 degrees and 30 degrees
Celsius). Humidity Ieveis must be maintained below 6Q% in accordance with CFR 21, sec 205 and
211.
7. provide one dedicated data quality analog phone line per Sensaphone0. The telephone line must
be a Plain Old Telephone Service (POTS) type line (this line may not be a shared line). Digital
lines on private branch exchanges (PBX) or private telephone switchboards will not work with the
Sensaphone0.
8. ensure one dedicated standard 120VAC, 60HZ, 10W, UL-listed power outlet power source per
Sensaphone0. The out{et should be connected to an existing facility emergency generator or the
location must provide an uninterruptible power supply (UPS) device.
9. provide a fire detection and alarm device and, adequate fire suppression in accordance with
applicable federal, state and local pharmaceutical regulations and fire codes.
10. provide standard lighting to ensure CHEMPACK personnel can clearly see lot numbers and
product expiration dates as required by applicable federal, state and local pharmaceutical
regulations.
���9y5
1. Is the cache location accessible to la�ge trucks?
(Accommodate 20 ft trailer and suitabie tum around space)
2. Is a loading dock orfork lift available?
3 a. 72° aisles and 34° doonvays in and out of the faciliiy.�
b. Nbst narrow Aisle:
c. Most narrow Doorway:
4. Sioped hallways and/or ramps (weight >700 Ibs)?
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5. Are freight elevators available that can accommodate the � �
container (weight >700 ibs)?
6. Do obstacles (doors/aisles) limit your movement route � �
options? Make a movement diagram if you answer "Yes".
Official CHEMPACK container dimensions: 60.5" (Height) X 32.5" (Width) X 6a.5" (Length)
7. 40 square feet per container?
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8. Room dimensions: Width_ft. x Length f(= _sq ft.
9. Total # Containers: x 40 sq ft=_(required sq. ft.)
Note: See attached cache storage facility diagram.
Reference: CFR Title 21, Part 211
� v. �yscem Lo maintain temperature between 59° to
11. Are humidity levels maintained below 60%?
12. Is there a(lockable) thermostat to regulate environmental
conditions? (recommended, but not required)
13. Are personnel designated to respond to correct room
temperature deviations within one hour of Sensaphone alarm?
14. Is there adequate lighting to ensure CHEMPACK personnel
can clearly identify lot numbers and product expiration dates?
15. Is the location free of pesticides, soivents, petroleum
products, and flammabie materials?
16. Is the cache �ocation clearof trash?
17. Does the cache location ha� pest control?
Reference: CFR Titie 21, Part 211
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0 5-99�
18. Is there one dedicated Plain OId Telephone System (POTS)
phone line per Sensaphone?
19. Total number of dedicated POTS phone line(s)
required:,
20. Point of Contact for POTS line verification:
21. Phone number for Point of Contact:
22 a. Is there one dedicated 120 VAC, 60 Hz power outiel
surge protection available per Sensaphone?
b. Total number of 120 VAC, 60 Hz outlet (s) required:
23 a. Is back-up emergency power available?
b. What Type: Facility emergency generator or
Uninterruptible Power Supply (UPS).
24. Distance (unobstructed) between phone line & outlet?
25. Does the storage location have controlled access that
meets the DEA requirements?
26. Is access to keys limited and controlled?
27. Is the key custodian the DEA registrant or a designated
representative?
28. Is a security or surveillance system available and
operational?
29. ldentify the type of security system.
Heat sensor, Motion sensor, Security camera.
30. Do the security or pharmacy personnel physically monitor
the sensor on a 24-hour basis?
31. Does the security system detect movement in and around
the CHEMPACK containers?
32. Are there personnel assigned to respond within 15 minutes
of a security alarm?
Reference: CFR Title 21, Part 1301.
33 a. Is there a fire detection system available?
b. What type?
34 a. Is there a fire suppressio� system available?
b. What type?
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It is recommended that the following issues be addressed prior to fielding.
Note: The DEA registrant signs a statement certifying that the iicense is vaiid for this site.
It is required that the below issues be addressed prior to fielding this location.
1 have been provided a copy of this Site Survey Checklist.
10/04/2005 16:Oa FAg 6512158895 �H OEP
0�=9y� �002
This agreement contains no public data under section 13.37 af the Minnesota
Statutes. Do not circulate-
MEMORANDUM OF AGREEMENT
BETWEEN THE
CENTERS FOR DISEASE CON7'R�L AND PREVENTION,
U.S. C?EPARTMENT OF HEAL7H AIVD HUMAN 3EltViCES
AND THE STATE OF MINNESOTA
l. Purpose
To effecfively respond to acts of chemicai terrorism and other public heafth
emergencies, the Ceniers for pisease Confral and Prevention (CDC) agrees to pre-
position sustainab{e repositories of nerve agent antidotes in locations in the State of
Minnesota. This MOA establishes the terms, canditions, and responsibilities between
the parties for deployment, management, and maintenance of this federally-owned
asset.
91. Parties
7he Parties to this MOA are the Centers for Disease Control and Preventian (CDC), a
component of the United States Department of Heafth and Human Services {HHS) and
fhe State of Minnesota acting fhrough its commissioner of health (State}, The CDG wili
carry out the responsibilities in this MOA an beha4f of the U.S. Department of tiealth and
Human 5ervices. CDC will implement this MOA through its Division of Strategic
National Stockpile (DSNS). The CDC and the State agree to the terms, conditipns. and
responsibilities expressed in this MOA.
III. Definitions
For purposes of this MOA, these terms shall be defined as follows:
CMEMPACK means the sustainable repository of nerve agent antidotes and other
necessary and certain supporting equipment to care for individuals exposed to nerve .
agents, including but not limited to auto-injectars, bulk symptomatic treatment supplies,
and self-monitonng sforage wntainers. CHEMPACK is a Component of the DSNS.
The CHEMPACK Project provides two types of containers: 1) The Emergency Medical
Service (EMS) container that is clesigned for use by emergency responders (materiel
packaged pnmarily in autainjectors) and 2) The Hospital container that is designed for
hospitai dispensing {materiel packaged primarily in multi-dose vials
LA-OO l V3 BACKUP OF CHEMPACK MOA.DOC
1 0/04/2005 18:09 FA% 6512158885 MDH pEP � 00�
,` 0�-99�
tor precision dosing and long term care). See CHEMPAEK Container contents,
Appendix 1, which is attached and made part of fhis agreemen�
She[f Life Extension Prugram (SLEA} means #he Food and Drug Administratian's
{FDA} shelf E'�fe extension program designed to rrtainfain the readiness and
effecfiveness of pharmaceuticals over extended periods of time. The SLEP defers costs
by extending fhe expiration date of stOfed pharmaceuticafs rather than replacing StoC[cS
that have reached a set expiration date. Through centrally focated automated
monifioring devices, the DSNS Program staff is able to ensure that conditions of
CHEMPACK materiel comply with SLEP guidelines, thus enabling CHEMPACK to
provide the State a long-term capabitrty.
fV. CDC Responsibilities
1. Defermine fhe contents and recommended doses of standardized
CNEMRACK container packages and a treatment formulary to treat patients
exposed to nerve agents.
2. Allocate the gmount of $1,897,087 for the CWEMPACK Project in Minnesota
State (excluding BT Cities as indicated}.
3. Procure and deliver the CNEMPACK materfei to cache storage locations
idenEified by the 5tate of Minnesota, subject to subsection 5 below; once the
� State has identifiied the required number and type of EMS or Hospital
CHEMPACK containers {within the funding amount a[located by the
CHEMPACK Project).
4. Provide 5ATC0� C Drug.EnforcementAgency (DEA) containers. The
CHEMPACK cantainers will be equipped with one padlock; a Sensaphone�;
a back-up temperature monitoring system and a DSNS Program seriai
nurttbered �ontainer Seal.
5. Determine in ifs sole discretion the suitability of CMEMPACK cache locations �
within Minnesota based on the critaria out4ined in section V of this agreemant_
6. Provide a DSNS Program fielding team to install the CHEMPACIC Gontainers
at.state desfgnated cache locations, conduct a joint inventory with designated
cache location personnef, and validate the operational status of CHEMPACK
environmental and security monitoring equiprrtent,
7: Ensura that Schedule EV controlfed substances are secured in a locked DEA
approved CHEMPACK container and thaf a State designated pharrnacy or
medicai professional wifh a DEA regisfratior� for that iocatian has inventoried
and assumed custody of the materiel.
LD-OO�V3 Cf�MpACK MOA'WTTT�T C]]C FAVAS. 06 29 OS_DOC 2
10/04/2005 16:04 FA% 6512158895 MDH OEP � 004
OS 99�'
8. Provide resources and assets required to sample, restock, re-tabel, and
dispose of CHEMPACK materiel subject to the SLEP,
9. Pravide resources antf assets required #o perform surveiliance and quality
assurance/quality.wntrol of CHEMPACK assets.
90.ConducY periodic actdits, including quality asSUrance and quality confrol
inspections, tp verify 4hat [insert name of Stafej is implementing proper
irtventory, sforage, and securify procedures for CHEMPACK assefs.
V. State ResponsibititOes
Autho�ze breaking the CHEMPACK container seal and use the packaged
products onfy when designated state officers, employees arid agents determine
that an accidental or intentional rierve agent release has threatened the medical
security of 4he community; has put multiple lives at a riSk; is beyond local
emergency response capabilities; and the materiel is medically necessary to
save lives.
2, Designate a single person to be the state-wide point of contact (POC} for
CHEMPACK. Provide that individual's contact numbers during normal business
hours and after hours (office phorre, cell phone, pager, email and fax). Also,
designate an altemate (APOC} to backup the State CHEPPPACK POG, and -
provide corresponding contact information. This information shall be provided to
the DSNS Program within 3Q days of the State's decision to participate in
CHEMPACK.
3. Notify DSNS Program of ariy changes in contact personnei wi4hin one business
day of assignment of a new POC 1 APOC.
4. Determine the quantity and iype of CHEMPACK containers (EMS / Hospital),
required to meet the needs of state and local frrst responders to respond to a
nerve agent event, (within stipulated budget constrairtts} and provide this
infort»ation fo the DSNS Program at least 60 days priar ta the ezpected state
fielding dates.
5. Deveiop a CHEMPACK �perational Plan for deployment, surveillance and
maintenance operations as an addendum to the State Emergency Response
Plan. The plan should address: asset placement; disfribution; cove�age areas;
security; pracedures for wntrol, authorization �nd use of CHEMPACK assets.
This pldn shall be pro�ided fo fhe DSNS Program at least 30 days prior to fhe
e�cpected state fielding dates.
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6. ProVide the address of each cache storage location and ensure pre�coordinated
access for DSNS Program personne! to cache loqtions as needed to moni�or
Cf1EMPACK materiel and provide this information to the DSNS Program af least
45 days prior to expected srafe fielding dates.
7. Ensure that cache storage locafions are of a suitabie size; designed to provide
adequate lighting, ventilatian, temperature control; provide sanitation, humidity,
and spaCe and secur'r!y cbnditions for storage of pharmaceuticals. See State
Responsibiiity for Cache Storage Standards for Schedule 4V Controlled
substances and Pharmaceuticals based upon the DEA, FDA, and DSNS
Progr�m Storage Criterion, contained in Appendix II which is aftached and made
part of this agreement.
8, Ensure proper disposal in accordance with appficabie federal, state, and local
reguiations af expired CHEMPACK medical materiel and provide copies of the
destrucfiion documentation ta ihe DSNS Program. See CHEMPACK medical
items the state is responsibie for disposing in accordance with applicable federal,
state, and local regulation, Appendix III, which is aftached and made part of this
agreement • ,
9. Conduct joint inven#ories with the CNEMPACK fielding tearY� upon initiaf
placement and approximately every 1$ months thereafter. Conduet monthly
securify checks to visually inspect DSNS Program seals on the CHEIVIPACK
containers (in accordance with appticable federal and state regulations fhe
perspn signing for custody musE be a Registered Pharmacist or his/her
designee).
10. Conduct quafity controi checks at each cache focation #o ensure the faCiliiy's
Gimate is within acceptabfe environmental limits and submit a monthfy
CHEMPACK Project quafify control {QC) checklist to document storage
conditions at the ceche location to DSNS Program.
11. Provide adequate transpor[ation of CHEMPACK materiel in an emerg.ency, to
include coorc{inating with sfate and local o�cials and emergency planning
members for use o{ vehicles, freeway roufes, and ai�elds.
12. Ensure storage facilities have.the capa6ility fo rapid►y move CHEMPACK
materie! as required. This may include, but is not limited to, hydraulie lifts,
forkl'rfts, toading docks, or ramps.
13, Provide a fist of personnel with access to the CFI�MPACK cpn#ainers at each
caGhe location to the DSNS Program POC at the time of fielding, and update as
changes occur.
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'R4.Ensure cache storage focations corcect non-complying environmentai and
security condifions identified by DBNS Program POC in a timely marYner (usua8y
within one hour). When conditions cannot be corrected wi#hirt 12 hours, fhe.
CFIEMPqCiC Logistics Team wifl coordinafe wifh the State CHEMPAGK POC to
move CHEMPACiC container(s} foan acceptab(e locatian to safeguard the quality
or security of the materiei.
15. Notify the CHEMPACK Logistics Team wrthin two hours if a CHEMPACK�cache
storage location lases climate controi. Any reporCS of materiel stared outside of
the accepted storage range will be handled on a case-by-case 6asis. Outcomes
could range from having the maferiel remain in the SLEP to removing the
materiei fram the SLEP program and the State fortei#ing the long-term
sustainability ofifhe resource.
16. Coorrlinate with DSNS Prpgram personneS fo ensure the mafntenance of proper
security and environmentaf conditions for CNEMPACK materiel during any non-
emergency movement (to include pre-posi#ioning assets for speCial events),
Movements of CHEMPqCK materiel not specifically directed by fhe DSNS,
Pragram shatl be funded by the State. See section IX of this agreement.
17. Notify the DSNS program within 24 hours of an emergency deploymenf. 7he
deployment report should identify the amount of CHEMPACK expended and the
amount of materiel retumed to the container.
18. in the event of a non-emergency use or compromise of ChiEMPACK materiel;
the stata wil{ repart the loss to the DSNS Program as soon as possibfe following
discovery, Within 4$ hours of the discovery of the loss the state must subrrtit a
report documenting the circumstances resulting in the toss and prqviding a
inventory of materiel'lost or destroyed.
V�• Cttsts
Except where otherwise det�iled in this MOA, each party is responsible far its own
costs. Any assistance provided 6y CDC under this MOA is subjeet to the availability of
apprppriations. The DSNS Program is not currently funded to replace any CHEMPACK
material used in response to an acYua( nerve agent incident. If such an event occurs,
however, the DSNS !'rogram wiH coopErate with the Stafe to identify mechanisms fo
rEplenish/replace expended CHEMPACK materia!_ Replacement ofi CHEMPACK
material due to circums�nces beyond the cnntro! of the parties, such as accident and
rtaturaE disasters, wil! be negotiated 6etween the Sfate and the DSNS program on a
case-by-case basis.
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Vil_ Ownership
The CDC shall at all times retain ownership of atl CHERt(PACK.materials. Subject to the
terms of ffiis MOA, CDE granfs the State permission to use CHEMPACK materials in
the everrt Qf an accidental or intentional nerve agent re(ease ffiaf threatens the medical
security of tf�e corrimunity, puts multiple lives a# risk, and is beyond local emergency
response capabil�ties, and the materiel is medical(y necessary to save lives.
VIIL Storage
Stafe and local agencies may only store the materiel provided as part of the
CHEMPACK Project in the DSNS-provfded containers, State-owned anci QSNS
Progrdm-owned nerve agent antidotes may not be co-mingled in storage containel's
since co-mingled storage will compromise the DSNS Program's ability to maintain the
materie( under the SLEP. The State may, however, siore State-owned materief af the
same cache location as the CHEMPqCiC containers.
iX. Movement fior 5peciaf Events
The CDC authonzes the State to move CHEMPACK for State-designated special
events (e. g„ National Spaci8l Security Events, Super Bowl, World Series, major
political conventions, sfiafe fair, a major concert, and key summits) on a Yemporary
basis. The femporary movement of CHEMPACK assets is subjecT W the following
condifions; (1) the State GH�MPACK pQC or backup must notfiy the DSNS Program at
least 48 hours prior to such mdvement of CHEMPACK containers; (2) the notification
must be made telephonicalfy or in writing (elecYronic or paper) to the designated DSNS
Prograrn state consultant, the CHEMPACK Regional Goordinator; or CNEMPACK
Prpject Manager; (3) the State sha�f ensure that environmental and security
requirements outlined in Section V are maintained throughout transport and
depfoyment; and {4) any movement of CHEMPACK materiel not specifically directed by,
the.DSNS Program shall be funded by the State.
X_ Gamplianee with U.S. Drug Enforcement Agency Requirements
The State agrees to comply with all appiicable federal, state, and local requirements
t�egaMing storage, use, and handling of cantro{{ed substances. A non-exctusive list of
federal requirements regacding the storage, use, and handling of these substances may
be found at Titie 21 Code of Federal Regulations Part 1301. In addition, the State
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agrees to designate a pharmaceutical or medicai professionaf with a DEA regisiration
who will sign for and accept custody for controlled substances and ofher
pharmaceutica►s ih CHEMPqCK containers at each cache storage location. The State
designee wili be responsible fol'the storage and safeguarding of control(ed substances
witliin the CHEMPACK container and ensure compliance with federal, stafe, and Iocal
requirements. The Stats POC must provide ffie custodian's name, license number and
contact informatipsl hn10 weeks prior to the scheduled delivery.of a cache location.
XI. Requesfis for Information
Under42 USC § 247d-6b, no federal agency shall disclose under 5 USC § 552, United
States Code, any inforrnation idenfrfying the location 8t which DSNS Program rnaterials
are stored. To the extent permitted by faw, the parties agree that ne'rther will dYsclose
the nature of this effort and the fierms of this agreement fo any person or entity except
as may be necessary to fulfi(I its mission and statutory and regulatory responsibilities.
The parties agree to notify one another befor� releasing materials ar informaFion relating
to GHEMPACK or this MOA pursuant to federal or state freedom of informa#ion act
statutes or similar provisions in I�w.
XII. Lia6ility
Each party to this agreement shall be responsibie 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 omissi6ns of enfities not a party fo this agreeme�t.
IVeifher party'to this N1pA agrees to release, hold fiarmless, or indemnify the other party
from fiability that may arise or relate to this Mpq.
X�1�• Effecf on Procedures and Laws
All ass;stance provided underthis MOA musf comply with applicabie faws, regulations,
and CDC agency policies.
XIV. No Private Right Created
This document is an intemal agreement between CDC and the State of MINNESpTA
and daes not create or confer any right or benefit on any other person or party, privaYe
or pub�ia Nothing in this agreement is intended to restrict the authority of either
signatpry to act as provided by Iaw or regulation, or to restrict any agency from
enforCing any laws within its authoriiy or jurisdiction,
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XV. Seftlement of Disputes
The parties agree to good faith consultation with one another to resolve disagreements
fhat may arise under or relating fo this MOA before referring t'he rnafter to any other
person ar enf"ity for settlerrment.
XVI. Authority
This agreement is made under the authority of section 311 of the Public Heatfh Service
Act (42 U.S.C, § 243) and 42 USC § 247d-6b.
XVEI. Term of Agreement
R. Effective Date: August 1, 2005, or the da4e the State obtains all required
signatures under Minnesota Statutes Section 16C.05, subdivision 2, whichever is
later.
B. Ex iration Date: Jufy 31, 2d14, or until alf obligaEions havc k�een satisfactorily
t'ulfilled, whichever occurs first.
XVlll. Amendments
Any amendment to this agreement must be in writing and wiil not be effective untif it
has been execUteq and approVed by the same part'ses who eXacuted and approved
the original agreement; or their successors in office..
XIX. Termination
This agreement may be terminated by either parly at any tirne; however, the
terminating par[y shall provide written notice to the other party dt least six manths in
advance of the ef#eCtive date of ter'mination uniess there is a critical failure to perfoRn.
In the event of fermination, all �SNS Program equipment, related records, and/or .
other materiel generated 6y or for the CHEMPACK Praject in iurtherance of this
agreement are property of the DSNS Program and shall be retumed to the DSNS
Program within six months of the terminatinn date.
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XX. Capacityr to Enter into Agreement
The persons executing this Memorandum of Agreement on behaFf of their respective
entities hereby represen# and warrant that fhey have fhe right, power, fegal capacity,
and appropriate authority to enter into this agreement on behalf Of the entiEy for which
they sign, ,
k • �C�.n tti �
Julie L. Gerberdin M. �
Director, Centers or
Disease Control and Pr�vention
s�P 15 �ao5
4ate Signed
Y
dianne M. Mand� ach �
Cammissioner
Minnesota Department of Heaith
� �, p
Da e Signed
Commissioner of Administration
as dNegsted m Maferiats management Oivisioh
By:
Tltl@:
Date:
6/23/OS
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Appendix ( — CHEMPACK Container Contents
Appendix II — State Responsibility for Cache Storage Standards for Schedule IV
Controlled Substances and Pharmaceuticais are based upon the
folfowing DEA and FDA Criterion
provide a locked room or cage. The CHEMPACK container is constructed of
LexanO mesh and is approved by the Drug Enforcement Agency (i.e., double
locked standard, 24/7 security monitoring, and controlled designated entry) for
storage of Class IV controlled substances. For this reason, there is no
requirement for floor to ceiling construction. The purpose of the enclosed room or
cage is to control access and ensure compliance with applicable federai, state
and local pharmaceutical regulations.
2. instali an intrusion detection device, directed towards the CHEMPACK
containers, to alert cache location security or pharmacy personnel of possible
intrusion into the storage area. The sensor must be physically monitored on a
24-hour basis by security or pharmacy personnel. Cache location security
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managers will test the interior devices according to manufacturer specifications to
ensure proper operation.
ensure each container is locked with a padlock and access to the key is limited;
key control shall be the responsibility of the DEA registrant and/or the cache
location pharmacy director.
4. ensure a minimum clearance of 72" aisles and 34" doorways to maneuver
containers in and out of the storage location.
5. provide a minimum of 40 sq. ft. of floor space per container at each cache
location.
ensure accessibility to CHEMPACK containers. CHEMPACK container
dimensions are 60.5" long X 32.5" wide X 60.5" high and weigh approximately
600 pounds, depending on container type.
7. ensure CHEMPACK containers are stored in a ciimate-controlled environment
with room temperature maintained between 59 to 86 degrees Fahrenheit (15
degrees and 30 degrees Celsius). Humidity levels must be maintained below
60% in accordance with CFR 21, sec 205 and 211.
8. provide one dedicated data quality analog phone line per Sensaphone0. The
telephone line must be a Plain Oid Telephone Service (POTS) type line (this line
may not be a shared line). Digital lines on private branch exchanges (PBX) or
private telephone switchboards will not work with the Sensaphone0.
9. ensure one dedicated standard 120VAC, 60HZ, 10W, UL-listed power outlet
power source per Sensaphone0. The outlet shouid be connected to an existing
facility emergency generator or the location must provide an uninterruptible
power supply (UPS) device.
10. provide a fire detection and alarm device and, adequate fire suppression in
accordance with applicable federal, state and local pharmaceuticai regulations
and fire codes.
11. provide standard lighting to ensure CHEMPACK personnel can clearly see lot
numbers and product expiration dates as required by applicable federal, state
and local pharmaceutical segulations.
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Append'sx III — CHEMPACK Medical Items the State 1s Responsibte For Disposing
In Accordance With Appiicable Federal, State, and Local
Regulations
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