Attachment 2 - Performance Work Statement .pdf

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Life Cycle Sustainment of Emergency Response Kits
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This document is a Performance Work Statement (PWS) for the life cycle sustainment of emergency response kits and warehousing services for the Department of State.

The key requirements include: procurement, assembly, labeling, storage, distribution, tracking, and sustainment of over 30 different emergency response kit configurations, as well as local and regional pharmaceutical stockpiles. The contractor will maintain databases to provide the government with real-time information on post supplies following an emergency. The contractor will also provide facility maintenance, repair, and storage of operational medicine kits, equipment, and aviation biocontainment components. Additionally, the contractor will provide transportation and management of the government's standing biocontainment-capable air medical evacuation capability. The contractor must maintain all necessary licenses and regulatory compliance to perform these services.

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Attachment 3 - Kit Level Component List.xlsx XLSX spreadsheet

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U.S. Department of State Life Cycle Sustainment of Emergency Response Kits

Directorate of Operational Medicine Attachment 2 – Performance Work Statement

C.1 PURPOSE

The Bureau of Medical Services, Directorate of Operational Medicine (MED/OM), through the

Office of Acquisitions Management (A/OPE/AQM), has a requirement to procure, assemble, distribute, and warehouse standardized emergency response kits and supplies, including the data management, tracking, and life cycle sustainment services of those kits and supplies to all

Department of State posts worldwide. Additionally, MED/OM is responsible for the whole-of-governments only standing biocontainment-capable air medical evacuation capability, and further carries a requirement for the transportation and deployment of these capabilities in times of crisis.

C.1.2 DEFINITIONS/ACRONYMS

ACO Administrative

Contracting Officer

Person with the authority to administer, change the terms and conditions of, or terminate the IDIQ.

CO Contracting Officer Person with the authority to enter into, administer or terminate contracts.

COR Contracting Officer’s

Representative

Individual designated and authorized in writing by the

CO or ACO to perform specific technical or administrative functions regarding this IDIQ and all its orders.

DOS Department of State The agency in the U.S. Government responsible for foreign affairs.

DO/TO Delivery Order / Task

Order

Order for supplies and installation (delivery order) or services (task order) placed against this IDIQ.

IDIQ Indefinite-delivery, indefinite-quantity contract

This contract, which requires the Government to place orders for delivery or performance to occur.

MED/OM Operational Medicine The Directorate is responsible for the development and implementation of standardized emergency medical training programs for DOS.

Post Embassy or consulate Any foreign service establishment maintained by the

U.S. Government abroad.

C.2 BACKGROUND

MED/OM is responsible for the development and implementation of standardized emergency medical training programs for the U.S. Department of State, as well as the development, resourcing, synchronization, and execution of medical support to global crisis response operations.

To accomplish that requirement, Foreign Service employees take part in one or more of over twenty different medical first responder courses offered through the National Foreign Affairs

Training Center, the Diplomatic Security Training Center, or through the Health Unit in their assigned post. With the diversity of coursework available, inter-operability became a major concern. In 2012, all curricula underwent extensive review and revision, resulting in the

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits development of the medical core curriculum, allowing all personnel to learn the same techniques, using the same materials, regardless of the course in which they took part.

One of the advantages of a standardized curriculum is the opportunity to standardize emergency response kit contents across the DOS enterprise, assuring that techniques learned in the classroom can be implemented by students correctly when needed. Standardization of kit contents, from the individual first aid kit through large kits designed to reconstitute an embassy health unit after an attack, yield significant efficiencies in supply chain management, training costs, and government buying power. Current equipment selections for the core curriculum are based on a kit configuration implemented under a pre-existing Department of State contract. The aforementioned contract was designed to support the Diplomatic Security Training Center and other Diplomatic

Security programs, and lacks sufficient funding authority to service the broad requirements of over

200 overseas posts.

Following the burning of the U.S. Embassy in Islamabad in 1979, and reinforced following the bombing of the U.S. Embassies in Nairobi, Kenya, and Dar Es Salaam, Tanzania, in 1998, the

Department recognized the importance of rapid reconstitution of the embassy health unit in supporting the larger Government response. Health unit reconstitution requires a large medical equipment assemblage. The Reserve Medical Unit Kit (RMUK) and the Expeditionary Medical

Unit Kit (EMUK) have evolved to satisfy that requirement. Unlike the smaller first response kits, the larger assemblies (RMUK, EMUK, and CALS bag) are replenished rather than replaced, requiring detailed annual replenishment planning and execution.

While the scope of services provided in each of over 200 diplomatic facilities around the world varies widely, from basic occupational health services in Paris to full spectrum resuscitation in

Baghdad, each is expected to maintain the capability to manage the first hour of a medical emergency, including cardiac arrest. While all locations have a resuscitation cart and the medical equipment to support that requirement, maintenance of proper emergency medications (including medical countermeasures for weapons of mass destruction) remains a significant challenge in procurement, tracking, data management, regulatory compliance, distribution, life cycle sustainment, and long-term change management. A decision was made by the Bureau of Medical

Services Pharmacy and Therapeutics Committee during second quarter 2015 to standardize emergency medications in post Health Units, and centralize procurement and distribution to capitalize on economy of scale.

In order to maintain a resilient and efficient global response capability, the Government will shift from post-specific stockpiles to regional stockpiles, requiring the establishment, staffing, and maintenance support services of a regional warehouse capability.

C.3 SCOPE

C.3.1 GENERAL

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits

The Contractor shall receive kit components from the Government and/or procure items on the

Government's behalf, assemble, label, store, distribute, track, sustain, and manage specific data elements for a series of emergency response kit configurations (hereafter referred to as “kitting”).

The Contractor shall make sufficient plans to store GFE related to the kitting process. This requirement includes over thirty (30) different kit configurations, as well as local and regional pharmaceutical stockpiles, with the flexibility to adapt those kits, or add new kits or stockpile contents, as the need arises. The Contractor will maintain a database of emergency response supplies distributed to the field in order to provide the government with an instant snapshot of post supplies following an emergency and inform long term life cycle logistics planning necessary to efficiently manage supply caches in the future. The Contractor will also maintain a database of

Occupational Health and WMD Countermeasure supplies distributed to the field in order to provide the government with an instant snapshot of post supplies following and emergency.

Additionally, the Contractor will provide a local facility dedicated to the routine maintenance, repair, calibration, deployment, and storage of Operational Medicine kits, equipment, and aviation biocontainment components.

The Government reserves the right to task the Contractor to lease, maintain, and manage secure warehousing facilities suitable for the storage of highly perishable and valuable response material stockpiles at any location around the world. The location will be mutually agreed to by the

Government and Contractor and execution of this task will be handled via contract modification.

Finally, the Directorate of Operational Medicine is responsible for comprehensive medical support to security, protection, and crisis response operations around the world, including special operations and aviation operations into critical threat environments and areas at risk for contamination following an event involving weapons of mass destruction. MED/OM is further responsible for the whole-of-government’s only standing biocontainment-capable air medical evacuation capability, with the ability to deploy specially designed containerized biocontainment systems on multiple types of aircraft. This capability is also the State Department’s only standing transoceanic aviation capability that can support air ambulance, the deployment of crisis responders, crisis logistics, and the deployment of security personnel to posts in crisis. Since the award of the original Everest 1.0 and Everest 2.0 contracting vehicles, it has become apparent that the Operational Medicine Program has expanded requirements outside of the realm of emergency medical kitting and can realize programmatic efficiencies by combining the management of its emergency medical kits programs with the management of MED/OM’s strategic pharmaceutical stockpiles of medications issued under the Occupational Health and Safety Act (OSHA) as well as its pharmaceutical stockpiles of weapons of mass destruction (WMD) countermeasures and antidote medications. By having these two disparate program segments tracked in the same system of record allows MED/OM to have a holistic view of all the medical kits and pharmaceutical countermeasures at its command to address an emerging medical threat at an overseas post.

Likewise, the inclusion of the storage and deployment of portable biocontainment medical evacuation systems incorporates another critical deployable capability into this consolidated contracting vehicle, also leveraging existing facility storage space to reduce costs to the

Department and better coordinate the deployment of multiple MED/OM response capabilities under a single umbrella.

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits

C.3.1.1 Program Management and Reporting

The Contractor shall provide comprehensive program management, including quality control, oversight, risk mitigation, and communication. The Contractor shall:

a) Obtain the necessary licenses and permits to deliver the required supplies to the Government, as required by applicable laws and regulations.

b) Wherever applicable, obtain all necessary country licenses, visas, and permits, and satisfy all required taxes and fees, necessary to operate within the place of performance, defined by mutual consent and bilateral modification, anywhere in the world.

c) Participate in meetings with the Government as requested to discuss performance under the contract. These meetings shall provide status updates and discuss ongoing regulatory, and shipment issues as applicable. These meetings shall be coordinated by the COR.

C.3.1.2 Customer Service and Support

The Contractor is expected to maintain a customer-focused approach to the work, ensuring a high level of customer satisfaction while operating within the terms and conditions of the contract. The

Contractor shall:

a) Return phone calls and emails from the CO, COR, or GTM within one business day. Calls placed by the Contractor in which the intended Government official cannot be reached shall be followed immediately by an email.

b) Meet the contractual requirements for timeliness, quality, and cost efficiency.

c) Establish and implement quality control procedures by proactively identifying risks, issues, and problems, and implementing plans for mitigation, whether under Contractor or DOS control.

d) Refer issues and problems immediately to the CO, COR, or appropriate GTM as applicable.

C.3.1.3 Meetings

a) The Contractor shall attend a post-award orientation / “kick-off” meeting with the CO and the

COR not later than three (3) business days after the date of award or a mutually acceptable date.

At the direction of the Government, this may be conducted as a teleconference. The purpose of the meeting is to review the final technical and contracting objectives of the statement of work and review the Contractor’s project plan.

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits

b) The Contractor shall attend an annual meeting, scheduled at the convenience of the Government and typically in the fourth quarter of each fiscal year (October-September) to review past performance and to go over the forecasts for the upcoming year’s requirements.

C.3.2 SPECIFIC AREAS OF SCOPE

The specific areas of scope include, but are not limited to the following:

• Acquisition of Response Equipment/Supplies (Section C.3.2.1)

• Assembly of Kits (Section C.3.2.2)

• Data Management and Material Tracking (C.3.2.3)

• Warehousing and Maintenance of Kits and Kit Components (C.3.2.4)

• Life-Cycle Sustainment/Replenishments (C.3.2.5)

• Aviation Biocontainment System Transport and Deployment Support (C.5.1)

C.3.2.1 Acquisition of Response Equipment/Supplies

a) For the purposes of this contract, a “kit” shall include any equipment, supply, or assemblage

(including initial acquisition, maintenance, ongoing technical support, and life cycle management) defined by the Government intended for use in the provision of medical support or training to high threat posts, medically austere locations, medical evacuations, emergency communications, or the protection of personnel providing direct tactical support to security, protection, or crisis response operations. This definition is intentionally broad in order to provide the Government with flexible and scalable options necessary to accomplish the missions of the Directorate of Operational Medicine, the Bureau of Medical Services, the U.S.

Department of State, and other supported Departments and Agencies of the U.S. Government in addressing complex and specific conditions of emerging natural and manmade disasters.

b) The Contractor shall establish and maintain a reliable supply chain for all kit components, including controlled and dangerous drugs regulated by the Drug Enforcement Administration and applicable state and local agencies, as defined by the Government. The components supplied shall be brand name or equivalent, with equivalency determined by the COR in advance of substitution. Substitutions that impact pricing require approval from the Contracting

Officer.

c) The Contractor shall notify the COR within one (1) business day should there be an unexpected disruption in the supply chain for the components of the required kit. The COR shall work with the Contractor to identify alternate sources of supply or acceptably equivalent substitutions.

Failure to recognize and report disruptions may result in unrecoverable costs by the

Government and result in an equitable price reduction (reference FAR Clause 52.246-2

Inspection of Supplies – Fixed-Price) to be determined by the Contracting Officer.

d) Non-pharmaceutical kit components shall have a service life, based on the marked expiration date of the component and the actual date of delivery of the kit, not less than twenty-four

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits months. Outer packaging of the components shall not be damaged or in any way altered in a manner that would reasonably be expected to result in a shortened service life of the component.

e) Determinations regarding the source of supply for pharmaceuticals required for kitting and labeling will be made based upon market conditions, pricing, and availability of specific medications. The Government may acquire medications (excluding intravenous fluids) required for kitting, and ship them in bulk to the Contractor for inspection, data entry, and placement in kits. Alternatively, the Government may require the Contractor to procure specific medications based on existing market conditions. Price and conditions shall be determined at the time of delivery order award. If the delivery order extends more than one contract year, price and conditions will be reviewed on a semi-annual basis, or more frequently as directed by the

Government.

f) Pharmaceutical kit components procured by the Contractor shall have a service life, based on the marked expiration date of the component and the actual date of delivery of the kit, not less than twelve months. Outer packaging of the components shall not be damaged or in any way altered in a manner that would reasonably be expected to result in a shortened service life of the component. Marking or secondary packaging shall not reduce the readability of the medication label.

C.3.2.2 Assembly of Kits

a) Kits shall be assembled in strict accordance with the list of contents specified in Section J, Appendix A, accounting for substitutions without a price impact, approved in advance by the

COR and modified from time to time by mutual consent between the Contracting Officer and

Contractor.

b) The Contractor shall maintain sufficient staff and physical space to adequately manage processes necessary to assemble, inspect, and maintain kits according to the Government’s specifications, including the implementation of quality control mechanisms that meet the standards set forth in the Quality Assurance Surveillance Plan below. All kits must be assembled and shipped in accordance with the approved distribution plan unless specifically authorized by the COR.

c) The Contractor must request all/any variances from the Government’s specification regarding kit assembly through the COR to the CO for consideration, with a detailed justification and description of any changes in price.

d) The Contractor must maintain the capability to vacuum seal kit contents in a protective encasement of clear plastic or similar construction (where specified by the Government) in order to meet form requirements and further protect the encased components.

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits

e) Each kit shall be assigned a serial number once assembled and tracked by the Contractor during its entire life cycle. All kits must be reported to the Government on both a periodic and an as-requested basis. See Sections C.6.1 and C.6.2.

C.3.2.2.1 Facility Requirements

a) The Contractor shall maintain adequate climate controlled and secure storage areas, shelving, racking, and other fixtures necessary to receive, process, log, and store medical and other sensitive materials prior to kit assembly. The space is subject to periodic inspection by the

Government at times mutually agreed upon by the Contractor and the COR.

b) Facilities used for the kitting and storage of kits must be equipped with an alarm system which is monitored 24-hours a day.

c) Kitting and storage areas shall be secure and climate controlled in a manner consistent with component manufacturer recommendations.

d) Kitting and storage facilities for medical materials shall be registered with the U.S. Food and

Drug Administration under their own Facility Establishment Identifier at the time of award.

e) Facilities used for kitting and storage of non-medical components, including communications and personal protective equipment, shall meet all relevant federal, state, and local certification requirements.

f) Facilities shall meet all state and federal requirements, and hold required certifications at the time of award, for storage of Pharmaceuticals and Controlled Substances for Non-Practitioners

Schedules II, III, IV, and V, in compliance with 21 CFR 1301.72(a) & (b).

C.3.2.2.2 Licensure and Regulatory Compliance

a) The Contractor shall possess and maintain all required licenses, certifications, and compliance systems necessary to perform under this contract on the date of award and throughout the period of performance.

b) The Contractor shall maintain annual State and Federal DEA Distributor license of Controlled

Substances for Schedule 2, 2N, 3, 3N, and 4 medications.

c) The Contractor shall maintain registration and reporting processes required to satisfy

Automation of Reports and Consolidated Orders System (ARCOS) requirements, and meet all state registration and reporting requirements for inventory and distribution records.

d) The Contractor shall maintain all state license(s) for Distributor of Dangerous Drugs and registration and reporting requirements of The Drug Supply Chain Security Act (DSCSA).

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits

e) The Contractor shall obtain and maintain FDA 510K registration and compliance for each kit assemblage, demonstrate past performance in managing projects through the 510K compliance process, and have systems and process in place to ensure compliance with 21 CFR Part 820 at the time of contract award.

C.3.2.3 Data Management and Material Tracking

a) The Contractor shall maintain a warehouse management information system to track orders for kit components, delivery date to the Contractor’s facility, lot and expiration date of components, and the final disposition of each component within a serialized kit. The technical solution for data management shall allow upload of existing stockpile data and entry of pharmaceutical data for new and existing international stockpiles. The warehouse management information system shall be configured to generate standard periodic and customized reports within 2 working days of a request from the COR.

b) In addition to the reporting standards and requirements described above, the Contractor will also integrate with the Program Office’s Enhanced Data Management Platform to provide real time data integration. During the time required to integrate into the Platform agreed upon with the Program Office, the Contractor will upload 1 (one) monthly inventory report into the

Program Office’s Enhanced Data Management Platform. This report will be uploaded as a single file in the comma separated values (.csv) file format — not an excel spreadsheet — and be a single document that encompasses all active inventory.

c) Upon final assembly, the Contractor shall place an assembly document inside the kit that indicates the kit serial number, date of assembly, kit contents, each component’s lot number and expiration date, and final destination if known at the time of assembly, and historical kit serial number that the assembled kit will replace or replenish at final destination. An electronic version of the kit assembly document shall be emailed to the COR in as a (*.pdf) file within one (1) business day of final kit assembly. All orders must be filled and shipped in accordance with the distribution plan approved at the time of order award unless specifically authorized by the COR. See Sections C.6.1 and C.6.2.

d) Contractor personnel involved in the performance of this task order in areas defined as “Data

Management and Material Tracking” must hold a Public Trust Clearance during the life of the contract.

C.3.2.3.1 Occupational Health and WMD Countermeasure Data Management

a) The Contractor shall maintain a data management information system to track pharmaceuticals related to the Operational Medicine’s subprogram supporting Occupational Health and WMD

Countermeasures. The data management information system will contain delivery date to the

Contractor’s facility, lot and expiration date of pharmaceuticals, reflect new data related to the

Shelf Life Extension Program (SLEP), and the location of the pharmaceuticals. The location of

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits the pharmaceuticals must further be tracked in accordance with the applicable Department of

Defense Account Activity Code (DODAAC) assigned to each Post. The technical solution for data management shall allow upload of existing stockpile data and entry of pharmaceutical data for new and existing international stockpiles. The warehouse management information system shall be configured to generate standard periodic and customized reports within 2 working days of a request from the COR.

b) In addition to the reporting standards and requirements described above, the Contractor will also integrate with the Program Office’s Enhanced Data Management Platform to provide real time data integration. During the time required to integrate into the Platform agreed upon with the Program Office, the Contractor will upload 1 (one) monthly inventory report into the

Program Office’s Enhanced Data Management Platform. This report will be uploaded as a single file in the comma separated values (.csv) file format — not an excel spreadsheet — and be a single document that encompasses all active inventory.

c) Contractor personnel involved in the performance of this task order in areas defined as

“Occupational Health and WMD Countermeasure Data Management” must hold a Public Trust

Clearance during the life of the contract.

C.3.2.3.2 Distribution of Kits

a) All labeling for onward shipment and destination for single item or bulk shipment of kits following assembly shall be identified by the CO at the order level or determined by the COR and communicated via technical direction to the Contractor.

b) Each box or container shall contain a shipment packing list, including the serial number for each kit in the shipment, a shipment tracking number, and the origin and destination of the shipment. An electronic version of the shipment packing list shall be emailed to the COR in as a (*.pdf) file within one (1) working day of final shipment from the Contractor.

C.3.2.4 Warehousing and Maintenance of Kits and Kit Components

a) The Government has a requirement for the establishment and management of warehousing facilities appropriate for the short-term and long-term storage of response kits and other medical materials. Warehousing facilities may be in any location worldwide that is mutually agreed upon by the Government and Contractor, based on the Government’s strategic needs that may evolve over time. Each facility shall implement security and environmental controls that are appropriate for the materials stored or transiting the facility, as approved by the COR, and comply with all applicable regulatory requirements specific to the location in which the facility is located. In establishing this warehousing service at a mutually agreed upon location, the

Contractor shall ensure materials are secured, tracked, and maintained through the approved warehouse management software system in use under the “Database Management” line of this contract, and that local biomedical maintenance services required for the maintenance of

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits medical equipment in storage are made available through the use of the Contractor’s employees or local subcontractors.

b) At the time of the award, the Contractor shall have an existing facility capable of maintenance and servicing biomedical devices including, but not limited to, the components found in

Appendix A, as well as storing existing response kits and other medical materials. The facility must adhere to the requirements found in Section C.3.2.2.1 Facility Requirements, paragraphs a through d, be a minimum of 14,500 square feet, and have a flush loading dock as well as a ground level freight bay capable of receiving a standard tractor trailer. Finally, the facility will be furnished with a forklift or pallet lift by the Contractor.

c) Maintenance services may include preventative maintenance, repair, or component replacement, and shall be defined at the establishment of the regional warehousing service or added by modification as requirements emerge. The Contractor is responsible for obtaining and maintaining all necessary permits, certifications, and licenses necessary to perform under this

Contract.

C.3.2.4.1 Repair and Unscheduled Maintenance of Operational Medicine Kit Components

a) Should the Government require routine maintenance, repair, and/or calibration services outside of the monthly scope defined in section C.3.2.4, the Government may seek to utilize a labor hour CLIN and should only be utilized to the extent that required services cannot be performed within the scope described above.

b) The labor category associated with this CLIN will be a Biomedical Engineer Technician

(BMET).

1. Functional Responsibilities: Provides support to the customer for: installation and maintenance of biomedical equipment; evaluation of existing biomedical equipment for reuse; installation, calibration and initial training of end-users in proper functioning and use of equipment; and evaluation of equipment requirements/specifications planned for new facilities including consideration of different categories of requirements including utilities, space and building infrastructure and support requirements. Works with other project personnel to resolve / clarify and any potential issues identified and refine and document resulting recommendations, equipment specifications, and installation calibration, testing and training activities.

2. Minimum Experience: Four (4) years of experience in biomedical equipment support field, including evaluation of equipment condition against established operating specifications, installation of new equipment and calibration and testing of equipment to ensure performance within defined specifications. Demonstrated ability to work with other personnel in a multi-disciplinary team assigned to support projects.

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits

3. Minimum Education: Must meet one (1) of the following minimum eligibility requirements: (1) Completion of a U.S. military (DoD) Biomedical Equipment

Technology program and two (2) years full-time BMET work experience; (2)

Associate’s Degree in biomedical academic program from an accredited college or university and two (2) years’ full-time BMET work experience; (3) Associate’s

Degree in Electronics Technology from an accredited college or university and three (3) years’ full-time BMET work experience; or (4) a Bachelor’s Degree from an accredited college or university and three (3) years’ full-time BMET (or BMET-adjacent) work experience.

c) The Contractor will ensure there is an auditable system for accountability for when the individual(s) is on-site outside of designated business hours.

d) For the purposes of this CLIN, unscheduled maintenance is maintenance that occurs during period of time that is not within the definition of “scheduled” as described below.

e) The Contractor will provide a monthly report to the COR of this accountability.

C.3.2.4.2 Scheduled Facility Security Management and Property Support

a) The Contractor shall provide dedicated property management support, to include provide responsibility for managing all activities that include overseeing all receiving and distribution operations; ensuring the security and accountability of all materials, equipment, and supplies;

plans and monitors optimal space utilization and efficient inventory flow; enforces processes and procedures for the logistical requirements and safe operations in and around the facility.

Specific duties will be defined by the Government as task orders as is deemed in the best interest of the Government. Contractor personnel performing under this CLIN will be trained and certified in accordance with OSHA (29 CFR 1910.178(i)(6)).

b) During periods covered by this service, designated representatives of the Government shall have unfettered access to the vendor’s facility under this CLIN.

c) For the purposes of this service, the term “scheduled” refers to weekdays between the hours of

8:15AM local time (EST/EDT) to 4:45PM local time (EST/EDT) with the exception of the following federal holidays:

Birthday of Martin Luther King, Jr.

Washington’s Birthday

Memorial Day

Juneteenth National Independence Day

Independence Day

Labor Day

Columbus Day

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits

Veterans Day

Thanksgiving Day

Christmas Day

C.3.2.4.3 Unscheduled Facility Security Management and Property Support

a) Should the Government require facility security management and/or property support outside of the monthly scope defined in section C.3.2.4.2, the Government may seek to utilize a labor hour CLIN in order to cover unscheduled support for crisis deployments, performing all the duties contemplated by section C.3.2.4.2, outside Department of State scheduled business hours as defined in C.3.2.4.2.

b) The labor category (LCAT) associated with this CLIN will be a Logistics Management

Specialist (LMS).

a. Functional Responsibilities: Provides support to the customer with: ensuring compliance with federal, state, and local warehousing, material handling, and shipping requirements by studying existing and new legislation; enforcing adherence to requirements; advising management on needed actions; safeguarding warehouse operations and contents by establishing and monitoring security procedures and protocols; controlling inventory levels by conducting physical counts; reconciling with data storage system — developing alternatives as required;

maintains physical condition of warehouse by planning and implementing new design layouts; inspecting equipment; issuing work orders for repair and requisitions for replacement; ensuring the security of warehouse products by designating storage areas; adjusting storage areas according to production and shipping requirements; updating a program-office provided database; and other duties as assigned.

b. Minimum Experience: Two (2) years work experience in the logistics management support field, including supply chain management, warehouse management, inventory control, or other related experience. Demonstrated ability to work with other personnel in a multi-disciplinary team assigned to support projects.

c. Minimum Education: Must meet one (1) of the following minimum eligibility requirements: (1) a Bachelor’s Degree from an accredited college or university and two (2) years’ full-time LMS (or LMS-adjacent) work experience; (2) completion of a U.S. military (DoD) Logistics Management Program or assigned duty role, and two (2) years full time LMS (or LMS-adjacent) work experience; or (3) a high school degree or equivalent (GED) and five (5) years full-time LMS (or LMS-adjacent) work experience.

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits

c) The Contractor will ensure there is an auditable system for accountability for when the individual(s) is on-site outside of designated business hours.

d) During periods covered by this service, designated representatives of the Government shall have unfettered access to the vendor’s facility under this CLIN.

e) For the purposes of this service, the term “unscheduled” refers to any time that is not covered within the definition of “scheduled” described above.

f) The Contractor will provide a monthly report to the COR of this accountability.

C.3.2.5 Life-Cycle Sustainment/Replenishments

The Contractor shall track all items with an expiration date by kit serial number or (in the case of pharmaceutical stockpiles) by geographic location, and provide detailed reports to the COR quarterly and as required, with projections for expiring kit components that will inform life cycle replenishment of expiring or outdated materials. Kit component reports shall be generated according to a schedule defined and modified as necessary by the COR. Replacement and replenishment kits shall be ordered by the Government as task orders according to this contract, or procured outside this contract, as is deemed in the best interest of the Government.

C.4 MEDICAL SETS, KITS, AND OUTFITS

C.4.1 Kits Requiring Periodic Replacement

C.4.1.1 Individual First Aid Kit (Sub-CLIN X003AA)

The Individual First Aid Kit (IFAK) is a single use, single patient medical kit, meant to be carried on the person or in hand luggage. The contents of the kit are meant to address immediate life threats for a short period of time until competent medical assistance arrives. This kit is designed for use by a layperson with basic medical training, and is procured by the Health Unit using post funds.

Items included in the IFAK are common through all kit product lines. See Appendix A for a list of kit components. This kit is replaced on a schedule determined by the Government.

C.4.1.2 Vehicle Medical Kit (Sub-CLIN X003AB)

The Vehicle First Aid Kit (VFAK) is a single use kit designed to provide immediate life-saving care for two to three patients, and is meant to be carried in every motor pool vehicle and as many personal vehicles as is practical at post. This kit is designed for use by a layperson with basic medical training. It is contained in a protective, hard plastic case, with contents grouped and vacuum sealed in a durable transparent envelope, and meant to be stored in an embassy vehicle.

See Appendix A for a list of kit components. This kit is replaced on a schedule determined by the

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits

C.4.1.3 Basic Trauma Kit (Sub-CLIN X003AC)

The Basic First Responder Kit (BASIC KIT) is a re-usable, multi-patient first responder bag designed to provide immediate life-saving treatment and wound care for a short period of time prior to or during transport to a medical treatment facility. It is designed for use by trained medical personnel, including Health Unit nursing staff and paramedical providers, although the contents are useful to anyone with basic medical training. See Appendix A for a list of kit components.

This kit is replaced on a schedule determined by the Government.

C.4.1.4 Advanced Trauma Kit (Sub-CLINs X003AD and X003AE)

The Advanced First Responder Kit (ADVANCED KIT) is a re-usable, multi-patient Advanced

Life Support bag designed to provide minimally invasive advanced trauma management and definitive wound care for a short period of time prior to or during transport to a medical treatment facility. It is designed for use by specifically trained nursing and paramedical staff, and other privileged medical providers with advanced trauma management training. There are pharmaceuticals in the Advanced Kit. There are no DEA Schedule medications in the Advanced

Kit. See Appendix A for a list of kit components. This kit is replaced on a schedule determined by the Government.

C.4.1.5 Personal Protective Equipment Kit (Sub-CLINs X003AF, AG, AH, AJ, AK)

The Personal Protective Equipment Kit (PPE KIT) is a single use, single provider, sized item that includes all necessary pieces of the U.S. Department of State approved infection control ensemble in a vacuum sealed protect wrap. It is designed for use by medical staff that must come in contact with patients infected with highly contagious pathogens. Every kit is built with 2 pairs of Medium, Large, and Extra Large KC100 gloves, and one pair of Medium, Large, and Extra

Large KC500 gloves. Sub-CLIN number is determined by the size of the Tychem QC Suit included

(Medium; Large, Extra Large; XXL; XXXL). See Appendix A for a list of kit components. This kit is replaced on a schedule determined by the Government.

C.4.1.6 Mass Casualty Triage Kit (Sub-CLIN X003AL)

The Mass Casualty Triage Kit (TRIAGE KIT) is a re-usable, multi-patient kit designed for use by trained triage team members, providing necessary supplies to render immediate first medical aid following a traumatic injury, and mark the casualty based on the level of severity of their injuries for transportation precedence. See Appendix A for a list of kit components. This kit is replaced on a schedule determined by the Government.

C.4.1.7 Health Unit Code Cart Kit (Sub-CLINs X003AM and X003AN)

The Health Unit Code Cart Kit is a standardized collection of emergency medications necessary to manage the first hour following a medical emergency in the Health Unit, including resuscitation of a patient in cardiac arrest. See Appendix A for a list of kit components.

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits

Pharmaceuticals may be provided as Government Furnished Equipment (Sub-CLIN X003AM) or procured by the Contractor (CLIN X003AN), as determined and articulated by the Government.

This kit is replaced on a schedule determined by the Government.

C.4.1.8 Medical Countermeasures – Advanced Kit (Sub-CLINs X003AP and X003AQ)

The Medical Countermeasures - Advanced (MCM-A) Kit is a single use collection of emergency medications specifically designed to provide advanced medical therapy for patients exposed to a chemical, biological, or radiological weapon, providing supplies for up to two patients for the first 24 hours post-exposure. See Appendix A for a list of kit components. This kit includes

DEA Schedule medications. Pharmaceuticals may be provided as Government Furnished

Equipment (Sub-CLIN X003AP) or procured by the Contractor (Sub-CLIN X003AQ), as determined and articulated by the Government. This kit is replaced on a schedule determined by the Government.

C.4.2 KITS THAT REQUIRE PERIODIC REPLENISHMENT

C.4.2.1 Comprehensive Advanced Life Support Venue Kit (Sub-CLINs X003AR and X003AS)

The Comprehensive Advanced Life Support Venue Kit (CALS VENUE KIT) is a re-usable, multi-patient Advanced Life Support kit designed to provide Advanced Trauma, Medical, Cardiac, and limited Pediatric care for short periods of time prior to or during transport to a medical treatment facility. It is designed for use by specifically trained medical, nursing and paramedical staff, and other privileged medical providers with advanced life support training. See Appendix A for a list of kit components. This kit includes DEA Schedule medications. Pharmaceuticals may be provided as Government Furnished Equipment (SubCLIN X003AR) or procured by the

Contractor (Sub-CLIN X003AS), as determined and articulated by the Government. This assemblage is replenished using one or more subcomponent replenishment kits on a schedule determined by the Government.

C.4.2.1.1 CALS Venue Kit – Non-Pharmaceuticals Replenishment (Sub-CLIN X003AT)

The CALS Venue Kit non-pharmaceutical replenishment provides end users with replacement expendable components of the Kit based on documented shelf life and programmatic requirements.

Non-pharmaceutical replenishments will be required no more frequently than biannually.

C.4.2.1.2 CALS Venue Kit – Pharmaceuticals Replenishment (Sub-CLINs X003AU and

X003AV)

The CALS Venue Kit pharmaceutical replenishment provides end users with replacement pharmaceutical components of the Kit based on documented shelf life of the individual medications and programmatic requirements. Pharmaceutical replenishments will be required no more frequently than semi-annually, with base programming using an annual replenishment

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits schedule. This kit includes DEA Schedule medications. Pharmaceuticals may be provided as

Government Furnished Equipment (Sub-CLIN X003AU) or procured by the Contractor (SubCLIN

X003AV), as determined and articulated by the Government.

C.4.2.2 Reserve Medical Unit Kit (Sub-CLIN X003AW and X003AX)

The Reserve Medical Unit Kit (RMUK) is a re-usable, multi-patient assemblage designed to reconstitute the occupational health and urgent care functions of a health unit following severe damage or destruction of the actual Embassy Health Unit facility. It is designed to provide up to five days of supply for a population of 150 persons, and assumes that host nation medical facilities are capable of caring for severely injured patients. A complete RMUK ordered under Sub-CLIN

X003AW or X003AX includes one of each RMUK Case below. This kit includes DEA Schedule medications. Pharmaceuticals may be provided as Government Furnished Equipment (Sub-CLIN

X003AW) or procured by the Contractor (Sub-CLIN X003AX), as determined and articulated by the Government. See Appendix A for a list of kit components. This assemblage is replenished using one or more subcomponent replenishment kits on a schedule determined by the Government.

C.4.2.2.1 RMUK CASE 1 – General Medical Supplies (Sub-CLIN X003AY)

RMUK Case 1 provides the medical provider with the general medical supplies necessary to provide diagnostic and urgent care services to a population of 150 persons.

C.4.2.2.2 RMUK CASE 2 – Basic Resuscitation Supplies (Sub-CLIN X003AZ)

RMUK Case 2 provides the medical provider with the medical supplies to provide basic resuscitative care.

C.4.2.2.3 RMUK CASE 3 – Basic Wound Care Supplies (Sub-CLIN X003BA)

RMUK Case 3 provides the medical provider with medical supplies necessary to provide basic wound care.

C.4.2.2.4 RMUK CASE 4 – Rehydration and Patient Movement (Sub-CLIN X003BB)

RMUK Case 4 provides litters, litter stands, and oral rehydration supplies necessary to establish a simple patient care area.

C.4.2.2.5 RMUK CASE 5 – Patient Holding Supplies (Sub-CLIN X003BC)

RMUK Case 5 provides limited medical supplies necessary to hold patients requiring continued medical care pending medical evacuation.

C.4.2.2.6 RMUK CASE 6 – Mortuary Processing (Sub-CLIN X003BD)

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits

RMUK Case 6 provides supplies necessary to properly prepare human remains for internment or transportation.

C.4.2.2.7 RMUK CASE 7 – Pharmaceuticals (Sub-CLINs X003BE and X003BF)

RMUK Case 7 provides limited pharmacy support necessary to manage urgent care and limited emergency medical care issues. This kit includes DEA Schedule medications. Pharmaceuticals may be provided as Government Furnished Equipment (Sub-CLIN X003BE) or procured by the

Contractor (Sub-CLIN X003BF), as determined and articulated by the Government. This kit is replaced on a schedule determined by the Government.

C.4.2.2.8 RMUK Replenishment – Non-Pharmaceuticals (Sub-CLIN X003BG)

The RMUK non-pharmaceutical replenishment provides end users with replacement expendable components of the Kit based on documented shelf life and programmatic requirements.

Nonpharmaceutical replenishments will be required no more frequently than biannually.

C.4.2.2.9 RMUK Replenishment – Pharmaceuticals (Sub-CLINs X003BH and X003BI)

The RMUK pharmaceutical replenishment provides end users with replacement pharmaceutical components of the Kit based on documented shelf life of the individual medications and programmatic requirements. This kit includes DEA Schedule medications. Pharmaceuticals may be provided as Government Furnished Equipment (Sub-CLIN X003BH) or procured by the

Contractor (Sub-CLIN X003BI), as determined and articulated by the Government. This kit is replaced on a schedule determined by the Government. Pharmaceutical replenishments will be required no more frequently than semi-annually, with base programming using an annual replenishment schedule.

C.4.2.3 Expeditionary Medical Unit Kit (Sub-CLIN X003BJ)

The Expeditionary Medical Unit Kit (EMUK) is a re-usable, multi-patient assemblage designed to support an advanced resuscitative capable within the Embassy Health Unit during periods when the host nation medical infrastructure is either unavailable or incapable of supporting critically injured patients awaiting medical evacuation. It is designed to provide sufficient equipment and supplies to support 4-6 critically injured patients for up to 48 hours pending medical evacuation.

Each EMUK ordered under these Sub-CLINs include (2) EMUK Hanging Bags, (2) EMUK

Medical Rucksacks, (1) EMUK Urgent Care Set, and (1) each EMUK Medical Electronics Sets (1 and 2). See Appendix A for a list of kit components. This assemblage is replenished using one or more subcomponent replenishment kits on a schedule determined by the Government.

C.4.2.3.1 EMUK Hanging Bag (Sub-CLIN X003BL)

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits

The EMUK Hanging Bag provides resuscitative supplies necessary to support two critically injured patients and is replenished according to the shelf life of the components and operational needs.

C.4.2.3.2 EMUK Medical Rucksack (Sub-CLIN X003BM)

The EMUK Medical Rucksack provides resuscitative supplies necessary to support two critically injured patients, packaged in an easily portable backpack configuration, and is replenished according to the shelf life of components and operational needs.

C.4.2.3.3 EMUK Urgent Care Set (Sub-CLIN X003BN)

The EMUK Urgent Care Set provides necessary medical equipment and supplies necessary to provide care for minor medical and surgical complaints in an austere clinical environment.

C.4.2.3.4 EMUK Replenishment (Sub-CLIN X003BO)

The EMUK Replenishment provides end users with replacement expendable components of the

Kit based on documented shelf life and programmatic requirements. Non-pharmaceutical replenishments will be required no more frequently than annually.

C.4.2.3.5 Protective Medicine - Expeditionary Medical Unit Kit (PM-EMUK) (Sub-CLIN

X003BP)

The Protective Medicine - Expeditionary Medical Unit Kit (EMUK) is a re-usable, multi-patient assemblage designed to support an advanced resuscitative capable within an austere medical environment during periods when the host nation’s medical infrastructure is either unavailable or incapable of supporting critically injured patients awaiting medical evacuation. It is designed to provide sufficient equipment and supplies to support 4-6 critically injured patients for up to 48 hours pending medical evacuation. Each PM-EMUK ordered under this Sub-CLINs include (2)

PM- EMUK Hanging Bags, (2) PM-EMUK Medical Rucksacks, (1) PM-EMUK Urgent Care Set, and (1) each PM-EMUK Medical Electronics Set. See Appendix A for a list of kit components.

C.4.2.3.6 PM-EMUK Hanging Bag (Sub-CLIN X003BQ)

The PM -EMUK Hanging Bag provides resuscitative supplies necessary to support two critically injured patients and is replenished according to the shelf life of the components and operational needs. The PM-EMUK Hanging Bag is specifically designed for austere medical environment for protective medical personnel.

C.4.2.3.7 PM-EMUK Medical Rucksacks (Sub-CLIN X003BR)

The PM-EMUK Medical Rucksack specifically designed for protective medical personnel in austere medical environments and it provides resuscitative supplies necessary to support two

U.S. Department of State Life Cycle Sustainment of Emergency Response Kits critically injured patients, packaged in an easily portable backpack configuration, and is replenished according to the shelf life of components and operational needs.

C.4.2.3.8 PM-EMUK Urgent Care Set (Sub-CLIN X003BS)

The…

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