7.19.2018_-_Everest_2.0_IDIQ_RFP_Document.docx

U.S. Department of State Medical Kit Life Cycle Sustainment

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Overview

The U.S. Department of State (“DOS”, “State”, or “the Department”), Bureau of Medical Services (MED), Directorate of Operational Medicine (MED/DMD/OM) 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 posts worldwide.

B.2 PRICING STRUCTURE

a) This is an indefinite-delivery, indefinite-quantity (IDIQ) contract, as defined in Federal Acquisition Regulation (FAR) 16.504 (Indefinite-Quantity Contracts) for non-commercial items.

b) Supplies and/or services to be procured will be identified at the delivery or task order level.

c) The contract type(s) for an individual order will be one or a combination identified in FAR Part 16 (Types of Contracts), depending on one or more of the factors identified in FAR 16.104 (Factors in Selecting Contract Types).

d) ‘X’ in CLIN identifier = Contract Year (e.g., 0 = Base Period; 1 = Option Year 1)

e) Firm-fixed-price (see FAR 16.202) = Payment at negotiated firm-fixed-price. Negotiated firm-fixed-price includes direct labor costs, direct non-labor costs, applicable indirect costs, and profit.

f) Firm-fixed-unit-price (FFUP) (see FAR 16.202) = Payment at negotiated firm-fixed-unit-price. Negotiated FFUP includes all direct costs, applicable indirect costs, and profit.

g) Cost Type (see FAR 16.302) = Payment at allowable actual incurred costs and applicable indirect costs. Payment of fee or profit is prohibited. Applicable indirect costs are calculated by multiplying negotiated applicable provisional billing indirect cost rates by actual incurred materials/other direct costs.

h) The Contracting Officer is the only person authorized to issue orders under this contract.

i) The following are the negotiated firm-fixed-prices for CLIN X001 (Data Management). The Pricing provided will be inserted into the appropriate task/delivery order for each contract period of performance. The negotiated firm-fixed-prices are payable at monthly intervals by dividing the firm-fixed-price for a given contract period of performance by the number of months in the period of performance (e.g., the monthly firm-fixed-price for the base period is calculated by taking the dollar figure identified below and dividing by 60). Each contract period’s firm-fixed-price represents the cumulative requirements for the CLIN.

Base Period: To be completed at time of award Option Year 1:

Option Year 2:

Option Year 3:

Option Year 4:

Option Year 5:

Six-Month Option to Extend (see FAR 52.217-8):

j) Section J, Appendix A, provides the composition of each medical kit and the negotiated firm-fixed-unit-price for each kit to be procured through CLIN X002 (Operational Medicine Sets, Kits, and Outfits) [Pricing will be inserted into Section J, Appendix J at time of award].

B.3 MINIMUM AND MAXIMUM contract QUANTITIES

a) The Government shall meet the contract minimum of $15,000.00 (inclusive of all direct costs, indirect costs, and profit/fee) through the issuance of order(s) within the contract’s period of performance.

b) The maximum quantity for the contract’s period of performance, including any extension(s), shall be any quantity or combination of supplies and services not exceeding $110,000,000.00 (inclusive of all direct costs, indirect costs, and profit/fee).

B.4 NOT-TO-EXCEED (NTE) PROFIT PERCENTAGES

a) This section applies when profit is an applicable element (e.g., under fixed-price, labor-hour, and time portion of time-and-materials arrangements) and when:

1. proposing and negotiating new cost elements (e.g., new medical kits, new labor categories) in the contract; and/or

2. changes (i.e., additions and/or deletions) in negotiated contract, task or delivery order pricing occur.

b) Examples of this section’s applicability are when proposing and negotiating:

1. Firm-fixed-unit-prices for medical kits not already identified in the contract;

2. Fixed-price task or delivery orders; and/or

3. equitable adjustments under fixed-price CLINs.

c) The following are the negotiated ceiling profit percentage(s):

Base Period: To be completed at time of award Option Year 1:

Option Year 2:

Option Year 3:

Option Year 4:

Option Year 5:

Six-Month Option to Extend (see FAR 52.217-8):

B.5 MATERIALS

a) This subsection applies to CLIN X003 (Other Direct Costs), which represents a cost-type arrangement.

b) This subsection will be used when the Government requires current and future in-scope supplies (i.e., supplies, materials, other direct costs) not attributable to other CLINs.

B.6 TRAVEL COSTS

a) Travel under this contract is generally defined as Contractor air and ground transportation, Contractor lodging, and Contractor meals and incidental expenses.

b) Travel costs shall be allocated to Sub-CLIN X001G (Other Direct Costs).

c) Except as otherwise provided herein, the Contractor shall be paid its allowable travel costs in accordance with FAR 31.205-46 (Travel Costs).

d) Travel must be directly related to and be required for performance of the contract.

e) Travel costs are authorized only for travel beyond a 50-mile radius of the Contractor employee’s local place of performance (official duty station) whenever work is required to be accomplished at a remote work site. No travel costs (or associated labor time during travel) shall be allowable for work performed at a Contractor’s local office or any other work site within a 50-mile radius of the Contractor employee’s local place of performance (official duty station). No travel costs (or associated labor time during travel) shall be allowable for telecommuting beyond (or within) a 50-mile radius of the Contractor’s local place of performance (official duty station).

f) Costs when using a privately owned vehicle (POV) for official travel are allowable provided that such costs do not exceed costs that would have resulted from use of other reasonable transportation methods (e.g., taxi, airplane, train). Reasonable associated costs, such as tolls and parking fees, are also generally allowable. The Contractor shall submit, as an attachment to its invoice, evidence to support the reasonableness of POV costs.

g) When traveling in a POV for official travel, the Contractor shall be paid mileage costs at a rate that does not exceed the POV mileage rate established by the Internal Revenue Service.

h) Costs for car rentals for official travel are allowable provided that: such rentals are consistent with good business practice; such costs do not exceed costs that would have resulted from use of other reasonable transportation methods (e.g., taxi, airplane, train); and such costs do not exceed the actual cost of renting a compact automobile (maximum of one automobile for four Contractor personnel), unless extenuating circumstances (e.g., excess baggage) require other arrangements and Contracting Officer or Contracting Officer’s Representative approval is obtained. Reasonable associated costs, such as tolls and parking fees, are also generally allowable.

i) The Government will pay the Contractor for each Contractor employee’s travel time to or from authorized work locations as long as such travel time is during the Contractor employee’s regular working hours during its normal 40-hour workweek (for performance inside the United States) or 60-hour workweek (for performance within the United States’ outlying areas and outside the United States), and such payment is in accordance with the Contractor’s established travel policy. For travel outside the United States, including its outlying areas (i.e., American Samoa, Federated States of Micronesia, Guam, Marshall Islands, Northern Mariana Islands, Palau, Puerto Rico, and Virgin Islands of the United States), travel time begins no earlier than three hours prior to the scheduled departure time and concludes upon arrival to the initial destination point (e.g., airport) at the place of performance. For travel inside the United States, travel time begins no earlier than two hours prior to the scheduled departure time and concludes upon arrival to the initial destination point (e.g., airport) at the place of performance. The Contractor shall not be paid for time spent in layovers that are for the convenience of the Contractor. The Government will not pay more than eight hours per day per Contractor employee for Contractor employees’ travel time when traveling inside the United States, and will not pay more than 10 hours per day per Contractor employee for Contractor employees’ travel time when traveling within the United States’ outlying areas and outside the United States. Exceptions must be authorized in advance and in writing by the Contracting Officer.

j) Travel must be authorized in advance by the Contracting Officer’s Representative or Government Technical Monitor.

k) The Contractor shall be responsible for ensuring that all personnel who will be required to travel outside the United States have a current and valid passport. The Contractor shall be responsible for obtaining any visas required for travel to foreign countries under this contract. The Contractor’s costs for obtaining and maintaining passports and/or visas will be generally allowable, but the Contractor shall pro-rate equitably such costs if they will benefit cost objectives (e.g., contracts) other than this cost objective. The Government will not reimburse the Contractor for travel expenses when travel is cancelled or modified as a result of the Contractor’s failure to obtain a visa. The Government will not reimburse the Contractor for the use of private visa procurement services provided by a third party.

l) If work under this contract will be performed at the Government site at the Department of State main building, 21st and Virginia Avenue, NW, Washington, DC 20520, or other State Annexes in the metropolitan Washington, DC area, daily commuting time and expenses between the Department of State site and some other location, such as a home office, shall not be allowable under this contract. However, commuting time and expenses between the Department of State site and some other location, such as a home office, shall be allowable when performing occasional official business (e.g., to attend a meeting at the Department of State site).

m) Pursuant to FAR 47.402, 47.403, and the Fly America Act, the Contractor is required to use a U.S.-flag air carrier service unless specific conditions exist. If such conditions exist, the Contractor shall submit with its voucher a memorandum explaining why it did not use a U.S.-flag air carrier service. Reimbursement is contingent upon Government acceptance of such explanation.

n) Foreign transaction fees for ATMs (automated teller machines) and credit cards while Contractor employees work overseas are allowable as long as such fees are in accordance with each of the following:

The Contractor shall show on each applicable voucher the details of the actual incurred foreign transaction fees for ATMs and credit cards while working overseas, including the rate of conversion and any commission charges.

B.7 DEFENSE BASE ACT (DBA) INSURANCE

a) DBA Insurance costs are unallowable for performance in the United States.

b) DBA Insurance costs are generally allowable for performance outside the United States, but only for covered Contractor and subcontractor employees. The following are covered Contractor and subcontractor employees:

1. United States citizens or residents;

2. Individuals hired in the United States or its possessions, regardless of citizenship; and

3. Local nationals and third country nationals where contract performance takes place in a country where there are no local worker’s compensation laws.

c) In addition, DBA Insurance costs are generally allowable for performance outside the United States, but only when such costs accord with the terms of the Contractor’s DBA Insurance policy, law, and regulation.

d) The Contractor’s DBA Insurance policy shall be with a carrier approved by the United States Department of Labor to provide DBA Insurance, or the Contractor shall be a self-insured employer authorized by the United States Department of Labor to provide DBA Insurance.

B.8 PERIOD OF PERFORMANCE

This contract is comprised of a five-year (60-month) base period plus five, one-year (12-month) option periods.

Base Period: To be inserted at award Option Year 1:

Option Year 2:

Option Year 3:

Option Year 4:

Option Year 5:

Six-Month Option to Extend (see FAR 52.217-8):

SECTION C – PERFORMANCE WORK STATEMENT (PWS)

C.1 PURPOSE

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

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 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 semi-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.

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.

C.3 SCOPE

C.3.1 GENERAL

The Contractor shall procure, assemble (hereafter referred to as "kitting"), store, distribute, track, sustain, and manage specific data elements for a series of emergency response kit configurations. 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. Further, 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.

Finally, 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.

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.

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)

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 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 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.

a) 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.

b) 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.

c) 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.

d) 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.5.1 and C.5.2.

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 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.

d) 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.

e) 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).

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

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).

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) 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. 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.5.1 and C.5.2.

C.3.2.3.1 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 assure 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 medical equipment in storage are made available through the use of the Contractor’s employees or local subcontractors.

b) 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.3.2.5 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 X002AA)

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 X002AB)

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 Government.

C.4.1.3 Basic Trauma Kit (Sub-CLIN X002AC)

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 X002AD and X002AE)

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 X002AF, 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 X002AL)

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 X002AM and X002AN)

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. Pharmaceuticals may be provided as Government Furnished Equipment (Sub-CLIN 002AM) or procured by the Contractor (CLIN 002AN), 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 X002AP and X002AQ)

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 X002AP) or procured by the Contractor (Sub-CLIN X002AQ), 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 X002AR and X002AS)

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 (Sub-CLIN X002AR) or procured by the Contractor (Sub-CLIN X002AS), 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 X002AT)

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 X002AU and X002AV)

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 schedule. This kit includes DEA Schedule medications. Pharmaceuticals may be provided as Government Furnished Equipment (Sub-CLIN X002AU) or procured by the Contractor (Sub-CLIN X002AV), as determined and articulated by the Government.

C.4.2.2 Reserve Medical Unit Kit (Sub-CLIN X002AW and X002AX)

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 CLIN 017 includes one of each RMUK Case below. This kit includes DEA Schedule medications. Pharmaceuticals may be provided as Government Furnished Equipment (Sub-CLIN X002AW) or procured by the Contractor (Sub-CLIN X002AX), 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 X002AY)

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 X002AZ)

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 X002BA)

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 X002BB)

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 X002BC)

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

C.4.2.2.6 RMUK CASE 6 – Mortuary Processing (Sub-CLIN X002BD)

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 X002BE and X002BF)

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 X002BE) or procured by the Contractor (Sub-CLIN X002BF), 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 X002BG)

The RMUK 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.4.2.2.9 RMUK Replenishment – Pharmaceuticals (Sub-CLINs X002BH and X002BI)

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 X002BH) or procured by the Contractor (Sub-CLIN X002BJ), 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-CLINs X002BJ and X002BK)

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 Set. 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 X002BK) or procured by the Contractor (Sub-CLIN X002BL), 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.4.2.3.1 EMUK Hanging Bag (Sub-CLIN X002BL)

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 X002BM)

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 X002BN)

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 X002BO)

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 X002BP)

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 X002BQ)

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 X002BR)

The PM-EMUK Medical Rucksack specifically designed for protective medical personnel in austere medical environments and it 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.4.2.3.8 PM-EMUK Urgent Care Set (Sub-CLIN X002BS)

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

C.4.3 KITS THAT ARE INITIAL ISSUE ONLY

C.4.3.1 EMUK Medical Electronics Set 1 (Sub-CLIN X002BT)

The EMUK Medical Electronics Set 1 provides necessary electronic life support equipment necessary to support two critically injured patients, including mechanical ventilation, transmission of biotelemetry, and electrical defibrillation, cardioversion, and transcutaneous pacing.

C.4.3.2 EMUK Medical Electronics Set 2 (Sub-CLIN X002BU)

The EMUK Medical Electronics Set 2 provides necessary electronic life support equipment necessary to support two critically injured patients, including bedside ultrasonography, controlled mechanical infusion of intravenous medications, store-and-forward medical imagery processing, portable laboratory analysis, advanced airway management, and highly portable automatic external defibrillation

C.4.3.3 Protective Equipment Set 1 (Sub-CLIN X002BV)

The provision of medical support to protection and security operations in high threat environments requires specifically designed and manufactured equipment, adapted to the medical mission. The Protective Equipment Set 1 (PES 1) provides operational equipment required for direct medical support to security and protection operations, including ballistic protection systems, weapons retention systems, optics, navigation systems, and other protective garments and gear.

C.4.3.4 Executive Protection Support Kit 1 (Sub-CLIN X002BW)

The provision of medical support to executive protection operations in politically sensitive environments requires specifically designed and manufactured equipment that provides high functionality with a minimal visible signature, adapted to the medical mission. The Executive Protection Support Kit 1 (EPS 1) provides operational equipment required for direct medical support to low visibility executive protection operations, including ballistic protection systems, weapons retention systems, communications equipment, and other…