W81XWH18R0013_SKO_Solicitation.pdf

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until 03:00 PM local time 16 Jul 2018

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X H 81 - 86 rudolph.j .spencer.civ@mail.mil

RATING PAGE OF PAGES

7. ISSUED BY

(Date)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

Previous Edition is Unusable 33-134 STANDARD FORM 33 (REV. 9-97)

Prescribed by GSA

FAR (48 CFR) 53.214(c)

DO-C9 1 86

(If other than Item 7)

15A. NAME 16. NAME AND TITLE OF PERSON AUTHORIZED TO

AND

ADDRESS

SIGN OFFER (Type or print)

OF

OFFEROR

AMENDMENT NO. DATE

15B. TELEPHONE NO (Include area code) 17. SIGNATURE15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

18. OFFER DATE

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

2. CONTRACT NO.

W81XWH 8. ADDRESS OFFER TO

See Item 7

9. Sealed offers in original and 5 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and

SEE BLOCK 7 ABOVE

conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME (NO COLLECT CALLS)

RUDOLPH J. SPENCER (301) 619-2789

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

2 - 10

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT X

PACKAGING AND MARKING

11 - 20

J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

22 - 23

24 - 25 X K

REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA 26 - 33 X

SPECIAL CONTRACT REQUIREMENTS

OFFER (Must be fully completed by offeror) 34 - 37 X M

L INSTRS., CONDS., AND NOTICES TO OFFERORS

EVALUATION FACTORS FOR AWARD

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments

AMENDMENT NO. DATE

to the SOLICITATION for offerors and related documents numbered and dated):

FACILITY

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period

SOLICITATION, OFFER AND AWARD

X

(X) SEC. DESCRIPTION (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE

26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE

EMAIL:TEL: (Signature of Contracting Officer)

CODE CODE

B. TELEPHONE (Include area code) C. E-MAIL ADDRESS

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) (4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

PART IV - REPRESENTATIO NS AND INSTRUCTIO NS

PART III - LIST O F DO CUMENTS, EXHIBITS AND O THER ATTACHMENTS

38 - 61

PART II - CO NTRACT CLAUSES

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

FAX:

TEL:

FAX:

TEL:

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

6. REQUISITION/PURCHASE NO.5. DATE ISSUED

16 May 2018

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

W81XWH-18-R-0013

Section B - Supplies or Services and Prices

SUPPLIES AND PRICES

B.1. CONTRACT

B.1.1. This acquisition is being issued as full and open competition in accordance with (IAW) Federal Acquisition

Regulation (FAR) 6.1 – Full and Open Competition, with a North American Industry Classification System

(NAICS) code of 339112 – Surgical and Medical Instrument Manufacturing.

B.1.2. The contract award shall be Multiple Award Indefinite Delivery Indefinite Quantity (MA-IDIQ) type contracts. Delivery Orders awarded under the contracts will be Firm-Fixed Price (FFP).

B.1.3. Contract awards will be made on a competitive basis, using Best Value Tradeoff Process procedures among price and non-price factors IAW FAR 15.101-1.

B.1.4. The number of contract awards will be determined by the number of Best Value Tradeoff Process offers the

Government can effectively manage. The Government intends to evaluate and award without discussions; however, the Government reserves the right to conduct discussions if determined to be necessary. If discussions are required, they will be conducted with Offerors IAW FAR 15.306.

B.2. GUARANTEED DELIVERY ORDERS

B.2.1. The estimated amounts identified in the Contract Line Item Number (CLIN) structure are placeholder values assigned to facilitate the issuance of Delivery Orders. These estimated amounts shall not be construed as an obligation of the Government for guaranteed Delivery Order value.

B.2.2. The guaranteed minimum for the entire IDIQ contract term is $15,000.00 which will apply during the first twelve months of the delivery period.

B.2.3. The anticipated maximum amount for the Sets, Kits, and Outfits program, inclusive of all options, shall not exceed $225,000,000.00.

B.3. ISSUANCE OF DELIVERY ORDERS

B.3.1. All SKO deliveries under this contract shall be set forth in individual Delivery Orders. All orders will be issued IAW the provisions of Section C, Section H, and all clauses listed in Section I. Clauses 252.216-7006

Ordering, 52.216-19, Order Limitation, 52.216-22 Indefinite Quantity, and 52.219-14 Limitation on Subcontracting shall be applicable to each Delivery Order.

B.3.2. Unit of issue for each FFP CLIN issued on each Delivery Order under this contract is “SET” or “EACH”.

The total quantity of “SET” equals the number of sets shipped on each Delivery Order. Each payment request shall not exceed the pre-negotiated Unit Price.

B.3.3. The maximum amounts identified in the Contract Line Item Number (CLIN) structure listed in Section B are placeholder values assigned to facilitate the issuance of Delivery Orders. These maximum amounts shall not be construed as an obligation of the Government or guaranteed Delivery Order value.

B.3.4. The Government anticipates award of one (1) Delivery Order from a single Delivery Order Proposal Request

(DOPR); however, the Government reserves the right to award more than one (1) Delivery Order from each DOPR.

B4. CONTRACT MINIMUM/MAXIMUM QUANTITY AND CONTRACT VALUE

The minimum quantity and contract value for all orders issued against this contract shall not be less than the minimum quantity and contract value stated in the following table. The maximum quantity and contract value for all orders issued against this contract shall not exceed the maximum quantity and contract value stated in the following table.

MINIMUM MINIMUM MAXIMUM MAXIMUM

QUANTITY AMOUNT QUANTITY AMOUNT

1.00 $15,000.00 50,000.00 $225,000,000.00

Reference clause FAR 52.216-19 Order Limitations for the minimum and maximum of one (1) order.

ITEM NO SUPPLIES/SERVICES MAX

QUANTITY

UNIT UNIT PRICE MAX AMOUNT

0001 7,000 Set Base Yr: Sets, Kits, and Outfits

FFP

The Contractor shall provide:

Sets, Kits, and Outfits in accordance with (IAW) the Statement of Need (SON).

See Attachment 01 for the Sets, Kits, and Outfits Supply Descriptions and MEC’s.

See Section L for Pricing Instructions.

Attachment 13-Price Workbook shall be completed in its entirety.

FOB: Destination

PSC CD: 6515

MAX

NET AMT

UNIT UNIT PRICE MAX AMOUNT

0002 3,000 Set Base Yr: Customized SKO's

FFP

The Contractor shall provide:

Customized Sets, Kits, and Outfits in accordance with (IAW) the Statement of

Need (SON).

See Section L for Pricing Instructions.

UNIT UNIT PRICE MAX AMOUNT

0003 10,000 Each Base Year Shipping & Handling

FFP

TO BE COMPLETED AT TIME OF DELIVERY ORDER

UNIT UNIT PRICE MAX AMOUNT

1001 7,000 Set OPTION OY1: Sets, Kits, and Outfits

FFP

The Contractor shall provide:

Sets, Kits, and Outfits in accordance with (IAW) the Statement of Need (SON).

See Attachment 01 for the Sets, Kits, and Outfits Supply Descriptions and MEC’s.

See Section L for Pricing Instructions.

Attachment 13-Price Workbook shall be completed in its entirety.

UNIT UNIT PRICE MAX AMOUNT

1002 3,000 Set OPTION OY1: Customized SKO's

FFP

The Contractor shall provide:

Customized Sets, Kits, and Outfits in accordance with (IAW) the Statement of

Need (SON).

See Section L for Pricing Instructions.

UNIT UNIT PRICE MAX AMOUNT

1003 10,000 Each OPTION OY1: Shipping & Handling

FFP

TO BE COMPLETED AT TIME OF DELIVERY ORDER

UNIT UNIT PRICE MAX AMOUNT

2001 7,000 Set OPTION OY2: Sets, Kits, and Outfits

FFP

The Contractor shall provide:

Sets, Kits, and Outfits in accordance with (IAW) the Statement of Need (SON).

See Attachment 01 for the Sets, Kits, and Outfits Supply Descriptions and MEC’s.

See Section L for Pricing Instructions.

Attachment 13-Price Workbook shall be completed in its entirety.

UNIT UNIT PRICE MAX AMOUNT

2002 3,000 Set OPTION OY2: Customized SKO's

FFP

The Contractor shall provide:

Customized Sets, Kits, and Outfits in accordance with (IAW) the Statement of

Need (SON).

See Section L for Pricing Instructions.

UNIT UNIT PRICE MAX AMOUNT

2003 10,000 Each OPTION OY2: Base Year Shipping & Handling

FFP

TO BE COMPLETED AT TIME OF DELIVERY ORDER

UNIT UNIT PRICE MAX AMOUNT

3001 7,000 Set OPTION OY3: Sets, Kits, and Outfits

FFP

The Contractor shall provide:

Sets, Kits, and Outfits in accordance with (IAW) the Statement of Need (SON).

See Attachment 01 for the Sets, Kits, and Outfits Supply Descriptions and MEC’s.

See Section L for Pricing Instructions.

Attachment 13-Price Workbook shall be completed in its entirety.

UNIT UNIT PRICE MAX AMOUNT

3002 3,000 Set OPTION OY3: Customized SKO's

FFP

The Contractor shall provide:

Customized Sets, Kits, and Outfits in accordance with (IAW) the Statement of

Need (SON).

See Section L for Pricing Instructions.

UNIT UNIT PRICE MAX AMOUNT

3003 10,000 Each OPTION OY3: Shipping & Handling

FFP

TO BE COMPLETED AT TIME OF DELIVERY ORDER

UNIT UNIT PRICE MAX AMOUNT

4001 7,000 Set OPTION OY4: Sets, Kits, and Outfits

FFP

The Contractor shall provide:

Sets, Kits, and Outfits in accordance with (IAW) the Statement of Need (SON).

See Attachment 01 for the Sets, Kits, and Outfits Supply Descriptions and MEC’s.

See Section L for Pricing Instructions.

Attachment 13-Price Workbook shall be completed in its entirety.

UNIT UNIT PRICE MAX AMOUNT

4002 3,000 Set OPTION OY4: Customized SKO's

FFP

The Contractor shall provide:

Customized Sets, Kits, and Outfits in accordance with (IAW) the Statement of

Need (SON).

See Section L for Pricing Instructions.

UNIT UNIT PRICE MAX AMOUNT

4003 10,000 Each OPTION OY4: Shipping & Handling

FFP

TO BE COMPLETED AT TIME OF DELIVERY ORDER

Section C - Descriptions and Specifications

STATEMENT OF NEED

Supply Statement of Need

U.S. Army Medical Materiel Agency (USAMMA)

Force Sustainment Directorate (FSD)

Sets, Kits and Outfits (SKOs)

Assemblies Requirement

STATEMENT OF NEED

Sets, Kits and Outfits (SKOs)

1. Purpose

The Defense Logistics Agency’s depots at Hill Air Force Base (AFB), Utah and Susquehanna, Pennsylvania have limited capacity and ability to meet many fiscal year procurement requirements of the U.S. Army Medical Materiel

Agency (USAMMA) Force Sustainment Directorate (FSD) Sets, Kits, and Outfits (SKOs). The Delivery Orders

(DOs) issued under this supply contract will serve to surge the capability of the Indefinite Delivery Indefinite

Quantity (IDIQ) contract to procure the low unit of measure and non-CLVIII items that are quite partial to all of the sets to achieve a higher percentage of fill for units. Some sets have significantly higher amounts of low unit of measure and non CLVIII items not currently supportable through DLA procurement and assembly, and surge requirements above DLAs capacity to provide. This contract for the USAMMA’s SKOs is to promote and enhance the Army Medical Department’s (AMEDD) ability to continue its global support to the U.S. Army Medical Force and America’s Warfighters at large.

2. Scope

2.1. The Government intends to award multiple (IDIQ) contracts to support USAMMA’s SKO requirement to supply medical, surgical, pharmaceutical, dental, laboratory, veterinary equipment, and material sets for the U.S.

Army medical units, nonmedical units and medical support programs with SKOs Supply requirement. These units and support programs include but are not limited to the U.S. Army Active, Reserve, National Guard Components;

Army Prepositioned Stocks program; and Foreign Military Sales program.

2.2. This supply Statement of Need (SON) has been reviewed and contains no supplies and services that are inherently governmental functions, as defined in Federal Acquisition Regulation (FAR) Part 2.1. The general services to assemble these SKOs are incidental to the overall supply requirements. The general scope of this requirement is to procure SKO components; label, assemble and pack these procured components into approved the

USAMMA SKO configurations.

3. Period and Place of Delivery Requirements

3.1. The period of delivery for this contract is proposed as follows:

Basic Year include Transition-in FY 2019/20 5 March 2019 – 4 March 2020

Option Year Period 1 FY 2020/21 5 March 2020 – 4 March 2021

Option Year Period 2 FY 2021/22 5 March 2021 – 4 March 2022

Option Year Period 3 FY 2022/23 5 March 2022 – 4 March 2023

Option Year Period 4 FY 2023/24 5 March 2023 – 4 March 2024

3.2. The place of delivery. Contractor shall deliver the assembled SKOs to various locations within the Continental

United States (CONUS) as Free-on-Board (FOB) Destination or mutually defined at time of Delivery Orders (DOs) issued under this contract.

4. Background

4.1. The USAMMA is a unique and multifaceted organization that serves as the Army Surgeon General’s central focal point and Executive Agent for strategic medical logistics programs and initiatives. The Agency’s mission is to develop, tailor, deliver, and sustain medical materiel capabilities and data in order to build and enable health readiness. Accordingly, the USAMMA’s principal skills and technologies focus on the medical logistician’s role in lifecycle management, sustaining and modernizing the medical force (Active, Guard, and Reserve), supporting exercises and contingency operations, and promoting medical logistics information and knowledge.

4.2. The USAMMA Production Assembly Management Division (PAMD) is organized under the USAMMA. The

FSD has principal responsibility for Army medical force management. Specifically, PAMD is responsible for planning and budgeting wholesale procurement, production, introduction, sustainment, and recovery of medical

SKOs and individual medical equipment items for the Army’s medical force, as well as nonmedical units with medical requirements (Active, Reserve, National Guard Components, and Army Prepositioned Stocks). This includes the full range of Planning, Programming, Budgeting and Execution (PPBE), procurement of SKO components and equipment, management of the SKO build process, distribution/fielding of medical SKOs, operational support of the Army medical units, and follow-on logistics support for medical systems and equipment to ensure combat ready forces in peacetime and during times of conflict. These actions are in direct support of the

USAMMA’s Core Competencies; Equip the Force and Sustain the Force.

4.3. USAMMA uses various acquisition vehicles to procure the items required within this document. The current

SKO IDIQ contracts for the USAMMA are as follows: W81XWH-14-D-0063 - TQM, LLC doing business as Two

Rivers Medical , W81XWH-14-D-0064 - The Lighthouse for the Blind doing business as LHB Industries, and

W81XWH-14-D-0065 - MSGI Corporation.

4.4. The terminologies of Medical Equipment Sets (MES), Medical Materiel Sets (MMS), Medical Unit

Assemblages (MUA), Unit Assemblages (UA), and SKO Assemblages are used interchangeably within the context of this SKOs contract Statement of Need (SON).

4.5. This contract will be available for use by all of the USAMMA directorates to include its worldwide activities supporting the U.S. Army Medical Research and Materiel Command (USAMRMC), the U.S. Army Medical

Command (MEDCOM), and the Department of Defense (DoD) Medical mission.

4.6. Due to the evolving nature of medicine practices, guidelines and doctrine, the subcomponents of the SKOs may be altered, updated or deleted.

5. Delivery Objectives

The Contractor shall use FOB Destination to ship SKOs to the Government’s authorized locations. The Contractor shall provide all necessary materials and labor to acquire FDA and DoD approved medical, surgical, dental, and pharmaceutical products in order to complete and build the medical SKOs that include, but are not limited to, the following:

5.1. Objective 1 – The Contractor shall possess product assembly capability for all SKOs (Section J: Attachment

01) to meet the USAMMA surge capacity requirements. The estimated order quantity for a 12 month period is in

(Section J: Attachment 13). Product assembly capability means that Contractor shall provide assembly services, space and warehouse shelf space when conducting procurement, sorting, assembly, packaging, storage (if required) and shipment of SKOs to military organizations, civilian organizations and Army Prepositioned Stock (APS) program.

5.1.1. The Contractor should possess a level of familiarity with the AMEDD process for developing, procuring, packing, marking, storing, and fielding SKOs; and familiarity with the DoD Medical Supply Chain and Logistics

Management infrastructure and systems.

5.1.2. The Contractor shall possess capability to assemble the SKOs in accordance with the provided listings of each

SKO and its components, sub-components with applicable quantities thereof, for all SKO requirements stated in each Delivery Order issued under the resultant IDIQ contract.

5.2. Objective 2 – The Contractor shall provide completed SKOs as specified in Delivery Orders issued under this contract. The completeness in building of medical unit SKOs is critical to the USAMMA’s Core Competencies in equipping and sustaining the U.S. Army Medical Force.

5.2.1. All SKOs shall be assembled with the accessories, supplies, and packed in whole as one complete unit prior to

Required Delivery Date (RDD) as specified in the Delivery Orders issued under this contract.

5.3. Objective 3 – The Contractor shall ensure that all SKOs will be shipped at 100% fill, unless otherwise approved by the USAMMA, within time and delivery requirements of the Delivery Order.

5.3.1. The fill rate is determined by those components identified on the Delivery Order. The Contractor shall provide medical SKOs with 100% fill rate of those components to meet the Government RDD.

5.3.2. At least bi-weekly the Contractor shall notify the appointed Contracting Officer’s Representative (COR) and the identified USAMMA Technical Advisors regarding the percent of fill for each SKO specified in Delivery Orders issued under this contract.

5.3.3. The Contractor shall provide a Certificate of Conformance (Deliverable 1, Section J: Attachment 02) for each Delivery Order with the invoices before the Government will accept and process payment requests in Wide

Area Workflow (WAWF).

5.3.4. In circumstances when the goal of the Delivery Order is not achievable, the Contractor shall notify the COR at least 45 days prior to the RDD. If the RDD is between 90 to 120 days after the Delivery Order award date, the

Contractor shall notify the COR at least 45 days prior to the RDD when the Delivery Order’s required delivery date is not achievable. If the RDD is less than 90 days after the Delivery Order award date, the Contractor shall notify the COR at least 15 days prior to the RDD when the Delivery Order’s required delivery date is not achievable.

5.3.5. In circumstances when the Contractor is unable to ship the SKOs at the required 100% fill rate and unable to meet the RDD, the Government will accept proposals or quotes with no less than 95% fill rate of the total components rolled up for each ordered SKO to meet the target RDD, or as otherwise specified at the Delivery Order level.

5.3.6. If the SKO configuration percentage fill rate is at least 95% but less than 100% of the Delivery Order, the

Contractor shall provide the COR a Certificate of Conformance with the exact percentage fill rate and listings of shortage items with invoice and payment request prior to submit to COR via Wide Area Workflow (WAWF).

5.3.7. If the SKO configuration percentage of fill is less than 95% at time of delivery, the Contractor shall provide a comprehensive Fill Rate Delivery Report (Deliverable 2, Section J: Attachment 03) in a Microsoft Excel spreadsheet format and shall submit this report to the COR and the identified USAMMA Technical Advisors. The

Contractor shall submit an update report every ten (10) business days thereafter until the Contractor can fulfill 100% of all component items for SKOs specified in the Delivery Order.

5.3.8. If the percentage of fill rate remains at least 95% but below 100% for more than 60 days after the RDD of initial delivery shipment, the Contractor shall not deliver the remaining items and shall not request for remaining payment without prior written approval obtained from the Contracting Officer.

5.3.9. The Contractor shall submit an Ad Hoc Report to both the COR and the Contract Technical Advisor (CTA)

(Deliverable 3), within 24 hours of request from the CTA, at any time after the Delivery Order is placed. The Ad

Hoc Report shall contain the working percentage of fill rate for each SKO ordered in the Delivery Order; contain working packing lists with all elements of data outlined in the Electronic Pack Data File Report (Deliverable 4, Section J: Attachment 04). Ad Hoc Reports will be submitted electronically, unless otherwise specified by the

COR. All electronic submissions must be compatible with the most current version of Microsoft Office Application.

5.4. Objective 4 – The Contractor shall comply and acquire healthcare products that have been approved by the

Food and Drug Administration (FDA), the Defense Health Agency (DHA), the DLA Medical Supply Chain, the

Defense Medical Materiel Office (DMMO), the AMEDD Directorate of Combat and Doctrine Development

(DCDD), the USAMMA and the USAMMA Project Management (PjM) Office.

5.4.1. The Contractor shall procure all necessary components for the SKOs. The Contractor shall comply with any and all required specialized licensing necessary in the acquisition of component requirements to the medical SKOs.

This includes but is not limited to clinical psychologist and veterinary licensing.

5.4.2. The Contractor shall conform and supply built SKOs with completed accessories and support components items as outlined within the Federal Logistics (WebFLIS) catalog file.

5.4.3. The Contractor shall have access to procure supply from the Government mandated federal supply schedules, Federal Catalogs, and DLA prime vendor program.

5.4.4. The Contractor shall be granted access to the Government’s Medical Services Information Logistics System

WebFLIS) http://www.webflis.us/database. This WebFLIS database supports the DoD Medical Logistics function and the Defense Medical Materiel Program Office (DMMPO). It is a central source for medical and nonmedical logistics data required to support the DoD’s health care missions. In order to meet the Minimum Essential

Characteristics (MECs) for each component item to build a complete SKO, the Contractor shall conduct an information search in WebFLIS for SKO components, relationships, consumable and support item report, hospital medical materiel sets, and Supply Catalogs for current SKOs. Procured components must be Non-Trade Agreement

Act (TAA) compliant.

5.4.5. The procurements of medical, surgical, dental, pharmaceutical, laboratory and veterinary component items for

SKOs are subject to the Buy American Act and the Berry Amendment Act.

5.5. Objective 5 – The Contractor shall mark individual components with the National Stock Number (NSN), short nomenclature, make, model, manufacturer, quantity and unit of issue. The Contractor shall ensure all SKOs are packed and labeled as specified for each Delivery Order issued under the contract. The accuracy of the information marked and labeled on components and each SKO is vital in the readiness and expedience of meeting surge requirements.

5.5.1. The Contractor shall assemble, label, pack, and mark the SKOs as required in individual Delivery Orders and

IAW applicable Federal and Army directives.

5.5.1.1 MIL-STD-129P (4), Department of Defense Standard Practice Military Marking for Shipment and Storage, 19 September 2007

5.5.2. The Contractor shall create an auditable record IAW the SKOs Delivery Orders issued under this contract.

5.5.3. The Contractor shall manage pharmaceutical component items; ensure availability of shelf life materiel at the date of delivery; and meet the requirements of the Delivery Orders.

5.5.4. The Contractor shall provide each box or container its own packing list, with all fields of information required in Section 5.5 reflecting each packed item in the SKOs container or box. The Contractor shall provide a packing list for each box or container to identify the component items contained therein.

5.5.5. The Contractor shall prepare and provide a Master Pack List (Deliverable 5, Section J: Attachment 05) for all SKOs. The Master Pack List shall be placed in the first container of the SKO. The packing list shall be, upon receipt of the equipment, readily available to the receiver at the shipping and destination point. This list will be used by the receiver as a checklist of items actually received and reported back to the COR.

5.5.6. The Contractor shall provide an Electronic Pack Data File Report no later than five (5) business days prior to the RDD, via electronic mail, as required for each Delivery Order. If any shortages are added after the Contractor submits the initial report, the Contractor shall provide a complete final report with updates only at the time of shipment. All electronic files must be compatible with the most current version of Microsoft Office Application.

5.5.7. The Contractor shall meet the standards of military packaging MIL-STD-2073-1D, Standard Practice for

Military Packaging in order to protect materiel against environmentally induced corrosion and deterioration, physical and mechanical damage, and other forms of degradation during storage, multiple handling, and shipment of materiel in the adverse operations environment.

5.5.8. The Contractor shall follow the DoD marking requirements for unique items IAW Defense Federal

Acquisition Regulation Supplement (DFARS) Clause 252.211-7003, Item Identification and Valuation and MIL-

STD-130, Identification Marking of U.S. Military Property as cited in each Delivery Orders issued under this

Contract.

5.6. Objective 6 – The Contractor shall meet standards in special handling, packaging, temperature sensitive medical products during shipment of the SKOs to delivery locations.

5.6.1. The Contractor shall ship each SKO IAW the RDD specified in each Delivery Order issued under this contract.

5.6.2. The Contractor shall ensure the proper process of marking, preparing temperature sensitive medical and pharmaceutical products for safety, packaging, handling, shipment, and storage utilizing approved equipment, alarm systems and procedures so that required temperatures are maintained throughout the supply chain until the

Government accepts the shipment.

5.6.3. The Contractor shall promptly, properly pack and ship the SKOs to meet the critical medical support mission readiness. It is imperative the shipping containers are appropriate for safeguarding those assembled components to prevent damage during shipment. General container and shipping information can be found in DTR 4500.9-R, Defense Transportation Regulation (DTR), Part II, Cargo Movement, June 2008.

5.6.4. Shipments shall be delivered, as directed by the Government, to the Contiguous United States (CONUS) including Alaska, and Hawaii. This will include, but is not limited to, areas of extreme heat and cold. The

Contractor shall provide appropriate shipping containers so the product will not be compromised by heat or cold following the manufacturer’s storage recommendations.

5.6.5. The Contractor shall develop and implement a Quality Control Plan (QCP) (Deliverable 6). The QCP details the methods and procedures that the Contractor will employ to ensure compliance with contract requirements and specifications in the areas of inspection, identification of deficiencies, correction of deficiencies, and documentation and reports. The Government Quality Assurance Surveillance Plan (QASP) will be used to evaluate the Contractor’s ability to control quality and performance through the proper administration of the QCP.

5.6.6. Prior to shipment, the COR will have access to the Contractor’s facility and all SKOs purchased and packaged, as required by the Government.

5.6.7. Shipment shall take place as defined in the Delivery Order. The Contractor shall notify the COR of any deviation from delivery schedule, within 72 hours. The Contractor shall ensure the Packing List is readily available to the receiving facility and personnel, along with the equipment. The packing list will include all requirements as established in Objective 5 and as specified in individual DOs issued under this contract.

6. Constraints

6.1. Organizational Conflict of Interest (OCI). The U.S. Army Medical Research and Materiel Command

(USAMRMC) has categorized all supply procurements into one (1) of the following three (3) categories as defined below, for purpose of identifying, avoiding or mitigating against Organizational Conflicts of Interest (OCIs) in accordance with (IAW) Federal Acquisition Regulation (FAR) Subpart 9.5. These categories are defined as follows:

Category 1 - Program and/or Administrative Support. Services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other Contractors’ proprietary information, or put the Contractor in a position to influence the award decision on a contract in which they are participating. Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate directorates/Commands.

Category 2 - Program Management Support. Services which assist in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business, process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or Subordinate

Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

Category 3 - Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, COTS Procurement and integration, internal development testing, deployment, installation, operations, and maintenance. Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

6.1.1. OCI Certification (Deliverable 7, Section J: Attachment 06). USAMRMC OCI Category 3 is applicable for this acquisition. The Contractor shall perform a thorough comparative analysis of the potential new work against all current and previous works performed in support of the USAISR organization and ascertain whether they have a possible conflict of interest. If there is a conflict of interest or the appearance of a conflict of interest, the Contractor shall provide a comprehensive OCI Mitigation Plan (See PWS Section 5.1). The Contractor shall complete the OCI

Certification at time of proposal submission.

6.2. This contract shall provide full support to the USAMMA SKOs and its activities located in CONUS and

Outside Contiguous United States (OCONUS). All specific delivery standards are identified in each DO with specific salient characteristics for each SKO and its components.

6.3. The components in each SKO are subject to change by the Government to fill the capability gap that are identified and validated by the USAMMA PjM Office. The SKOs for each service component with the U.S. Army and the DoD are different and depend on the unit’s type and its mission. The Service Component 1 known as Active

Duty units, normally require standard SKOs with Potency and Dated (P&D) medical and pharmaceutical products.

The SKOs for Service Component 2 known as Reserve Component and Component 3 known as National Guard may not require P&D products. On the other hand, regardless of service components, customized SKOs with specific

RDDs may be required for Special Forces and Civil Affair Units based on their unique mission, level of risk, operating environment and deployment timeline during surge operations in response to contingency operations such as natural disaster relief, humanitarian operations, conflicts and war time.

6.4. Each SKO has an assigned NSN approved by the DLA; however, there are components of SKOs which do not have an assigned NSN. Instead a UA (Unit Assemblage) number will be used to track the version of the SKOs managed by the USAMMA. Each component item in each SKO has its own NSN, but not all. In that case, the

Government will temporarily use the manufacture product number until a NSN is approved and updated in the

WebFLIS, and the Defense Medical Product Databank (MedPDB).

6.5. The Contractor shall contact the COR, and the Contracting Officer if there is a Delivery Order requirement in question or additional information and clarification is needed.

6.6. The Contractor shall not travel to the USAMMA SKO fielding location(s).

6.7. The Contractor shall not incur costs to perform work under any specific Delivery Order in excess of the price authorized for the Delivery Order. Only a written notice by the Contracting Officer may change any pricing or requirements under this contract or any Delivery Order issued hereunder.

6.8. The DoD Medical Standardization concepts are applicable to this supply contract.

6.9. The Occupational Safety and Health Act (OSHA) is applicable to this supply contract requirement.

6.10. The Anti-Terrorism (AT) by Fostering Effective Technologies Act of 2002 (SAFETY Act) (see Subpart 50.2) is applicable IAW the DoD AT/OPSEC Guidebook.

6.11. The Foreign Military Sales Program is applicable to this supply acquisition.

6.12. The Government will not furnish any equipment or facility during the life of this contract requirement.

6.13. The Government will provide complete information in the form of a requirements list for each SKO Delivery

Order issued under this contract. These SKOs will be configured as described in the Delivery Orders. Any exceptions will require pre-approval by the Contracting Officer.

7. Contract Administration

7.1. Government Purchase Card

The Contracting Officer and Government Purchase Card (GPC) Ordering Officer(s) are the only authorized buyers under this MA-IDIQ contract. The position titles of the appointed GPC Ordering Officers will be defined at the time of contract award. Delivery Orders issued by anyone other than the Contracting Officer and GPC Ordering

Officer(s) will not be honored without prior written approval from the Contracting Officer.

7.2. The Contract Administration Team will consist of the following members:

7.2.1. The Contracting Officer will have overall responsibility for administering this contract. The Contracting

Officer is the only person authorized to make changes to this Contract. A Contract Administration Plan (CAP) will be developed which identifies all functional positions, roles, responsibilities, coordination, and procedures to be performed in the contract administration and surveillance effort. The Contracting Officer will manage contract administration and quality assurance surveillance functions supported by contract administrators, the COR, quality assurance personnel, property administrators, cost and price analysts, and legal personnel, as applicable.

7.2.2. The Contracting Officer will be supported by the Chief of Contracts Management Division at the USAMMA and designated COR(s) who are required to properly administer the contract and ensure the Contractor is operating in accordance with the contract performance standards and all other contract requirements. The contract administrators must ensure all performance under this contract, and any required modifications comply with the contract requirements.

7.2.3. The COR will be appointed in writing via the COR Tracking Tool (CORT) and will be directly responsible to the Contracting Officer. The COR will monitor and document contract performance to ensure that the requirements of the contract are being satisfactorily executed by the Contractor. The COR may take actions, as delegated, which could lawfully be taken by the Contracting Officer except for changing the terms or conditions of the contract.

7.2.4. The COR will be assisted by the USAMMA Functional Unit’s Delivery Order Technical Advisors who also are known as Contract Technical Advisors (CTAs) will have the overall responsibility for surveillance of the

Contractor’s delivery to ensure controls are established and implemented pursuant to the Delivery Orders and

QASP. The CTA has duties and responsibilities as appointed by the USAMMA Commander in writing and will include the following:

7.2.4.1. Assist the appointed COR in conducting procedural reviews to determine if the Contractor’s methodical approach is complying with all technical aspects of the contract.

7.2.4.2. Assist the appointed COR in reviewing the Contractor’s Quality Control Plan (Deliverable 6) to ensure the

Contractor has adequately responded to the support requirements the Government enumerated in the supply SON.

7.2.4.3. Provide assistance to the COR in establishing contract surveillance procedures and methods.

7.2.4.4. Serve as the Assessing Official’s Representative by providing assessment of overall contract performance in

Contractor Performance Assessment Reporting System (CPARS).

7.2.5. The Contractor shall submit to the COR a SKO Quarterly Report (Deliverable 10) stating the percentage of fill versus the percentage of late fill and no fill of all required items on each Delivery Order. This Quarterly Report will be sent in both electronic and hard copy form.

8. Applicable Directives and References

The following directives and references are listed for support of this supply Statement of Need. Digital publications are available at the Army Publishing Directorate http://www.apd.army.mil/ .

- AR 40-61, Medical Logistics Policies and Procedures dated 08 January 2005

- AR 702-7-1, Reporting of Product Quality Deficiencies within the U.S. Army

- AR 702-18, Materiel Quality Storage Standards Policy for Shelf-Life Materiel

- AR 725-50, Requisition, Receipt, and Issue System

- DoD 4120.24-M, Defense Standardization Program (DSP) Policies and Procedures

- Federal Acquisition Regulation (FAR)

- Defense FAR Supplement (DFARS)

- Army FAR Supplement (AFARS)

- MIL-STD-129P, DoD Standard Practice Military Marking for Shipment and Storage

- MIL-STD-2073-1D, DoD Standard Practice for Military Packaging

- Technical Manual 38-470, Storage and Maintenance of Army Prepositioned Stock Materiel

- DTR 4500.9-R, Defense Transportation Regulation (DTR), Part II, Cargo Movement, June 2008

- DLM 4000.25, Defense Logistics Management System, Volume 2, Reporting of Supply Discrepancies, June 13,

9. Deliverables

The Contractor shall provide deliverables as described in the below table and subsequent Delivery Orders.

Deliverables shall be specified by the government.

E: Electronic H: Hard Copy TBD: To be determined http://www.apd.army.mil/

Item Reference Title Distribution E H Submission Requirement

SON 5.3.3,

SON 5.3.6

Certificate of

Conformance

COR

Contract

Technical

Advisor (CTA)

1 1 Each Delivery Order

2 SON 5.3.7

Fill Rate Delivery

Report

COR

CTA

1 0 IAW individual Delivery Order

3 SON 5.3.9 Ad Hoc Report

COR

CTA

1 0

Within 24 Hours after request from

CTA

SON 5.3.9,

SON 5.5.6

Electronic Pack

Data File Report

COR

CTA

1 0

Within 24 Hours after request from

CTA and NLT 5 business days prior to RDD

5 SON 5.5.5 Master Pack List

COR

CTA

1 1 Each Delivery Order

SON 5.6.5,

SON 7.2.4.2

Quality Control Plan COR 1 0

Initial submission with proposal.

Subsequent submission(s) as changes occur

7 SON 6.1.2 OCI Certification COR 1 1 Initial submission with proposal

9 SEC. H.1

Non-Disclosure

Statement

COR 1 1

The Contractor shall sign the Non-

Disclosure statement no later than

30 days after the contract is awarded.

10 SON 7.2.5 Quarterly Report COR 1 1 Quarterly

10. Related Documents – See Section J

Section D - Packaging and Marking

D.1. Packaging and Marking

D.1.1. The Contractor shall assemble, label, pack and mark the Sets, Kits and Outfits as required in individual

Delivery Orders.

D.1.2. The Contractor shall meet the standards of military packaging MIL-STD-2073-1D, Standard Practice for

Military Packaging in order to protect materiel against environmentally induced corrosion and deterioration, physical and mechanical damage, and other forms of degradation during storage, multiple handling, and shipment of materiel in the adverse operations environment.

D.1.3. The Contractor shall meet the standards of uniform military marking for shipment and storage. The marking of shipments will be IAW MIL-STD-2073-1D and Object 5 and 6 of the Statement of Need.

D.2. Temperature Sensitive Medical and Pharmaceutical Products

D.2.1. The Contractor shall ensure the proper process of marking, preparing temperature sensitive medical and pharmaceutical products for safety, packaging, handling, shipment, and storage utilizing approved equipment, alarm systems and procedures so that required temperatures are maintained throughout the supply chain until the

Government accepts the shipment.

D.2.2. The Contractor shall maintain the manufacturer specified environment conditions to ensure the potency, purity, and chemical composition of medical and pharmaceutical products that require controlled storage temperatures. The Contractor shall meet the medical and pharmaceutical storage and handling IAW the manufacturer product information, Army Regulation 40-61 Medical Logistics Policies and Supply Bulleting 8-75-

11.

D.3. DoD Unique Item Identification

D.3.1. The Contractor shall follow the DoD marking requirements for unique items IAW DFARS Clause 252.211-

7003, Item Identification and Valuation and MIL-STD-130, Identification Marking of U.S. Military Property as cited in each Delivery Orders issued under this Contract.

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government

0002 Destination Government Destination Government

0003 Destination Government Destination Government

1001 Destination Government Destination Government

1002 Destination Government Destination Government

1003 Destination Government Destination Government

2001 Destination Government Destination Government

2002 Destination Government Destination Government

2003 Destination Government Destination Government

3001 Destination Government Destination Government

3002 Destination Government Destination Government

3003 Destination Government Destination Government

4001 Destination Government Destination Government

4002 Destination Government Destination Government

4003 Destination Government Destination Government

CLAUSES INCORPORATED BY REFERENCE

52.246-2 Inspection Of Supplies--Fixed Price AUG 1996

52.246-16 Responsibility For Supplies APR 1984

CLAUSES INCORPORATED BY FULL TEXT

52.246-15 CERTIFICATE OF CONFORMANCE (APR 1984)

(a) When authorized in writing by the cognizant Contract Administration Office (CAO), the Contractor shall ship with a Certificate of Conformance any supplies for which the contract would otherwise require inspection at source.

In no case shall the Government's right to inspect supplies under the inspection provisions of this contract be prejudiced. Shipments of such supplies will not be made under this contract until use of the Certificate of

Conformance has been authorized in writing by the CAO, or inspection and acceptance have occurred.

(b) The Contractor's signed certificate shall be attached to or included on the top copy of the inspection or receiving report distributed to the payment office or attached to the CAO copy when contract administration (Block 10 of the

DD Form 250) is performed by the Defense Contract Administration Services. In addition, a copy of the signed certificate shall also be attached to or entered on copies of the inspection or receiving report accompanying the shipment.

(c) The Government has the right to reject defective supplies or services within a reasonable time after delivery by written notification to the Contractor. The Contractor shall in such event promptly replace, correct, or repair the rejected supplies or services at the Contractor's expense.

(d) The certificate shall read as follows:

"I certify that on ______ [insert date], the ____ [insert Contractor's name] furnished the supplies or services called for by Contract No._____ via ____ [Carrier] on ________[identify the bill of lading or shipping document] in accordance with all applicable requirements. I further certify that the supplies or services are of the quality specified and conform in all respects with the contract requirements, including specifications, drawings, preservation, packaging, packing, marking requirements, and physical item identification (part number), and are in the quantity shown on this or on the attached acceptance document."

Date of Execution: _______________________________

Signature: ______________________________________

Title: __________________________________________

(End of clause)

Section F - Deliveries or Performance

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 05-MAR-2019 TO

04-MAR-2020

N/A US ARMY MEDICAL MATERIEL AGENCY

US ARMY MEDICAL MATERIAL AGENCY

693 NEIMAN STREET

FREDERICK MD 21702

W25MWY

0002 POP 05-MAR-2019 TO

N/A (SAME AS PREVIOUS LOCATION)

0003 POP 05-MAR-2019 TO

N/A (SAME AS PREVIOUS LOCATION)

1001 POP 05-MAR-2020 TO

04-MAR-2021

N/A (SAME AS PREVIOUS LOCATION)

1002 POP 05-MAR-2020 TO

N/A (SAME AS PREVIOUS LOCATION)

1003 POP 05-MAR-2020 TO

N/A (SAME AS PREVIOUS LOCATION)

2001 POP 05-MAR-2021 TO

04-MAR-2022

N/A (SAME AS PREVIOUS LOCATION)

2002 POP 05-MAR-2021 TO

N/A (SAME AS PREVIOUS LOCATION)

2003 POP 05-MAR-2021 TO

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 05-MAR-2022 TO

04-MAR-2023

N/A (SAME AS PREVIOUS LOCATION)

3002 POP 05-MAR-2022 TO

N/A (SAME AS PREVIOUS LOCATION)

3003 POP 05-MAR-2022 TO

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 05-MAR-2023 TO

04-MAR-2024

N/A (SAME AS PREVIOUS LOCATION)

4002 POP 05-MAR-2023 TO

N/A (SAME AS PREVIOUS LOCATION)

4003 POP 05-MAR-2023 TO

N/A (SAME AS PREVIOUS LOCATION)

52.242-15 Stop-Work Order AUG 1989

52.242-17 Government Delay Of Work APR 1984

52.247-15 Contractor Responsibility for Loading and Unloading APR 1984

52.247-34 F.O.B. Destination NOV 1991

Section G - Contract Administration Data

CONTRACT ADMINISTRATION

G.1. PAYMENT

G.1.1. Payment procedures will be indicated on each Delivery Order.

G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

G.2.1. The COR for this contract shall be assigned via the CORT Tracking Tool.

G.2.2. Additional information on the Contract Administration Team (CAT) can be located in the Statement of

Need, Section 7.

G.3. DELIVERY ORDER COR

G.3.1. The Contracting Officer will designate a Delivery Order COR when the total value of the Delivery Order exceeds $150,000.00. The Delivery Order COR could potentially be the same COR as the Base contract and will serve as the primary point-of-contact for all activities and issues that occur under each Delivery Order. The

Contracting Officer shall assign (in writing) via a separate appointment letter at the time Delivery Order award.

G.4. CONTRACT MANAGEMENT

G.4.1. It is the Contractor’s responsibility to contact the Contracting Officer immediately if there is even the appearance of any technical direction that is or may be outside the scope of the contract. The Government will not reimburse the Contractor for work the Contracting Officer or the GPC Ordering Officers did not authorize and for work outside the scope of the contract.

G.4.2. The Contractor shall immediately notify the Contracting Officer for clarification when a question arises regarding the authority of any person to act for the Contracting Officer under the contract.

G.4.3. The Contractor shall submit to the COR a SKO Supply Requirement Quarterly Report (SON Section 7, Deliverable 10) stating the percentage of fill versus the percentage of late fill and no fill of all required items on each Delivery Order. This Quarterly Report will be sent in both electronic and hard copy form.

G.5. INTERPRETATION OR MODIFICATION

G.5.1. No verbal statement by any person, and no written statement by anyone other than the Contracting Officer, or his/her authorized representative acting within the scope of his/her authority, shall be interpreted as modifying or otherwise affecting the terms of this contract. All requests for interpretation or modification shall be made in writing to the Contracting Officer or Contract Specialist.

G.6. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

G.6.1. The Government will review monthly performance, with the…